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Cochrane Database of Systematic Reviews

Early additional food and fluids for healthy breastfed full‐term infants

Information

DOI:
https://doi.org/10.1002/14651858.CD006462.pub4Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 30 August 2016see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Pregnancy and Childbirth Group

Copyright:
  1. Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Hazel A Smith

    Correspondence to: Paediatric Intensive Care Unit, Our Lady's Children's Hospital, Dublin 12, Ireland

    [email protected]

  • Genevieve E Becker

    BEST Services, Galway, Ireland

Contributions of authors

Previous version of the review

Genevieve Becker co‐ordinated the review update. Genevieve Becker and Tracey Remmington assessed study eligibility independently extracted data and entered data. Genevieve Becker wrote the first draft with input from Tracey Remmington (Becker 2014).

Current version of the review

Hazel A Smith co‐ordinated the review update. Hazel A Smith and Genevieve Becker assessed study eligibility independently extracted data and entered data. Hazel A Smith lead on the analysis aspects and Genevieve Becker lead on the text; both authors agreed the final draft.

Sources of support

Internal sources

  • G Becker and HA Smith undertook the update of this review as volunteers with no funding or protected time support, Ireland.

External sources

  • Cochrane Pregnancy and Childbirth received a grant from the Evidence and Programme Guidance Unit, Department of Nutrition for Health and Development, World Health Organization, Switzerland.

Declarations of interest

In October 2012 Hazel A Smith registered as a PhD student to study the effects of infant's milk diet at two months of age on their body composition, growth and neurodevelopment in the first 2 years of life. Hazel is the Research Coordinator for the Paediatric Intensive Care Unit in Our Lady's Children's Hospital, Ireland. Hazel is not in receipt of any financial relationship with any commercial entity.

Genevieve Becker works in the general area of infant and young child feeding but not specifically connected with the topic of this review. Genevieve is not in receipt of any financial relationship with any commercial entity.

Acknowledgements

We are grateful to Sharon Remmington for her contribution to the protocol (Remmington 2007) and the initial version of this review (Becker 2011) and to Tracey Remmington for her contribution to all previous versions (Remmington 2007; Becker 2011; Becker 2014).

We are grateful to the study authors and their colleagues who provided further information, and to those people who noticed the requests and directed us to additional studies and ways of contacting authors.

Thanks are also due to Sonja Henderson (previous Managing Editor), Frances Kellie (Managing Editor), and Leanne Jones (Associate Editor), over the years of this review and their colleagues in the Review Group office of Cochrane Pregnancy and Childbirth.

Cochrane Pregnancy and Childbirth received a grant from the Evidence and Programme Guidance Unit, Department of Nutrition for Health and Development, World Health Organization (WHO). The findings, interpretations and conclusions expressed in this paper are entirely those of the authors and should not be attributed in any manner whatsoever to WHO.

Version history

Published

Title

Stage

Authors

Version

2016 Aug 30

Early additional food and fluids for healthy breastfed full‐term infants

Review

Hazel A Smith, Genevieve E Becker

https://doi.org/10.1002/14651858.CD006462.pub4

2014 Nov 25

Early additional food and fluids for healthy breastfed full‐term infants

Review

Genevieve E Becker, Tracey Remmington

https://doi.org/10.1002/14651858.CD006462.pub3

2011 Dec 07

Early additional food and fluids for healthy breastfed full‐term infants

Review

Genevieve E Becker, Sharon Remmington, Tracey Remmington

https://doi.org/10.1002/14651858.CD006462.pub2

2007 Apr 18

Early additional food and fluids for healthy breastfed full‐term infants

Protocol

Sharon Remmington, Tracey Remmington

https://doi.org/10.1002/14651858.CD006462

Differences between protocol and review

We updated the Background section and refocused to reflect exclusive breastfeeding as the norm and supplementation as an intervention, as well as more justification for the outcomes selected for examination.

Outcomes as listed in the protocol amended to (primary) physiological jaundice, absence or presence, and if present, duration (days), and (secondary) phototherapy in hospital or home setting if required, absence or presence, and if present, duration (days). This was changed in recognition that some participants are likely not to be jaundiced or to need phototherapy.

In the 2016 update, the outcomes "Weight change" was changed to "Measures of weight, growth and development" so as to include measures such as height, head circumference, and developmental aspects that may be included in trials, and "Maternal self‐confidence in breastfeeding" was changed to "Confidence in breastfeeding" in order to include trials that examined confidence of fathers and other family members, health workers or those with significant influence on the mother. Infant morbidity examples were expanded to include hypoglycaemia and symptoms of allergy.

We have updated the methods in accordance with the updated Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). In the 2016 update, we have assessed the evidence using the GRADE approach and added 'Summary of findings' tables.

Notes

In the next update, we will review the outcomes listed for their relevance in the future, and combine/reduce outcomes related to jaundice and hyperbilirubinaemia.

Keywords

MeSH

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figures and Tables -
Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Non‐exclusive breastfeeding infants (artificial milk) versus exclusive breastfeeding infants, Outcome 1 Breastfeeding duration.
Figures and Tables -
Analysis 1.1

Comparison 1 Non‐exclusive breastfeeding infants (artificial milk) versus exclusive breastfeeding infants, Outcome 1 Breastfeeding duration.

Comparison 1 Non‐exclusive breastfeeding infants (artificial milk) versus exclusive breastfeeding infants, Outcome 2 Allergy symptoms.
Figures and Tables -
Analysis 1.2

Comparison 1 Non‐exclusive breastfeeding infants (artificial milk) versus exclusive breastfeeding infants, Outcome 2 Allergy symptoms.

Comparison 1 Non‐exclusive breastfeeding infants (artificial milk) versus exclusive breastfeeding infants, Outcome 3 Incidence of fever.
Figures and Tables -
Analysis 1.3

Comparison 1 Non‐exclusive breastfeeding infants (artificial milk) versus exclusive breastfeeding infants, Outcome 3 Incidence of fever.

Comparison 1 Non‐exclusive breastfeeding infants (artificial milk) versus exclusive breastfeeding infants, Outcome 4 Maternal self‐confidence ‐ Modified breastfeeding self‐efficacy score at 1 week.
Figures and Tables -
Analysis 1.4

Comparison 1 Non‐exclusive breastfeeding infants (artificial milk) versus exclusive breastfeeding infants, Outcome 4 Maternal self‐confidence ‐ Modified breastfeeding self‐efficacy score at 1 week.

Comparison 1 Non‐exclusive breastfeeding infants (artificial milk) versus exclusive breastfeeding infants, Outcome 5 Phototherapy in hospital or home.
Figures and Tables -
Analysis 1.5

Comparison 1 Non‐exclusive breastfeeding infants (artificial milk) versus exclusive breastfeeding infants, Outcome 5 Phototherapy in hospital or home.

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 1 Breastfeeding duration.
Figures and Tables -
Analysis 2.1

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 1 Breastfeeding duration.

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 2 Maximum temperature (ºC).
Figures and Tables -
Analysis 2.2

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 2 Maximum temperature (ºC).

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 3 Minimum temperature (ºC).
Figures and Tables -
Analysis 2.3

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 3 Minimum temperature (ºC).

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 4 Episodes of hypoglycaemia (glycaemia < 2.2 mmol/L).
Figures and Tables -
Analysis 2.4

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 4 Episodes of hypoglycaemia (glycaemia < 2.2 mmol/L).

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 5 Mean capillary blood glucose levels of infants (mmol/L).
Figures and Tables -
Analysis 2.5

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 5 Mean capillary blood glucose levels of infants (mmol/L).

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 6 Weight change (loss) (g).
Figures and Tables -
Analysis 2.6

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 6 Weight change (loss) (g).

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 7 Weight loss (%).
Figures and Tables -
Analysis 2.7

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 7 Weight loss (%).

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 8 Maximum serum bilirubin levels umol/L.
Figures and Tables -
Analysis 2.8

Comparison 2 Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants, Outcome 8 Maximum serum bilirubin levels umol/L.

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 1 Fever (% of days).
Figures and Tables -
Analysis 3.1

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 1 Fever (% of days).

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 2 Cough (% of days).
Figures and Tables -
Analysis 3.2

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 2 Cough (% of days).

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 3 Congestion (% of days).
Figures and Tables -
Analysis 3.3

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 3 Congestion (% of days).

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 4 Nasal discharge (% of days).
Figures and Tables -
Analysis 3.4

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 4 Nasal discharge (% of days).

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 5 Hoarseness (% of days).
Figures and Tables -
Analysis 3.5

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 5 Hoarseness (% of days).

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 6 “Food allergy” to one or more foods between 1‐3 years of age.
Figures and Tables -
Analysis 3.6

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 6 “Food allergy” to one or more foods between 1‐3 years of age.

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 7 Visible eczema at 12‐month visit stratified by visible eczema at enrolment.
Figures and Tables -
Analysis 3.7

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 7 Visible eczema at 12‐month visit stratified by visible eczema at enrolment.

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 8 Food protein enterocolitis syndrome positive response to challenge (number of children).
Figures and Tables -
Analysis 3.8

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 8 Food protein enterocolitis syndrome positive response to challenge (number of children).

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 9 Weight change (gain) (g).
Figures and Tables -
Analysis 3.9

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 9 Weight change (gain) (g).

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 10 Weight change (z score).
Figures and Tables -
Analysis 3.10

Comparison 3 Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants, Outcome 10 Weight change (z score).

Summary of findings for the main comparison. Non‐exclusive breastfeeding (artificial milk) versus exclusive breastfeeding

Non‐exclusive breastfeeding (artificial milk) versus exclusive breastfeeding

Patient or population: healthy breastfeeding full‐term infants
Setting: hospital settings USA, Sweden and the Czech Republic
Intervention: non‐exclusive breastfeeding infants (artificial milk)
Comparison: exclusive breastfeeding infants

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with exclusive breastfeeding infants

Risk with non‐exclusive breastfeeding infants (artificial milk)

Any breastfeeding at discharge

Study population

RR 1.02 (0.97 to 1.08)

100
(1 RCT)

⊕⊕⊝⊝
LOW 1, 2, 3

980 per 1000

1000 per 1000

(951 to 1000)

Any breastfeeding at 3 months

Study population

RR 1.21
(1.05 to 1.41)

137
(2 RCTs)

⊕⊕⊝⊝
LOW 1, 2, 4, 5

765 per 1000

925 per 1000
(803 to 1000)

Infant morbidity ‐ allergy symptoms ‐ Infants with allergy symptoms at 18 months of age

Study population

RR 0.56
(0.35 to 0.91)

207
(1 RCT)

⊕⊝⊝⊝
VERY LOW 5, 7

327 per 1000

183 per 1000
(114 to 297)

Weight change

This outcome was not reported.

Maternal self‐confidence

Modified breastfeeding self‐efficacy score at 1 week. Items rated on a scale from 1 (“Strongly Disagree”) to 5 (“Strongly Agree”), with positive scores associated with increased breastfeeding self‐efficacy.

The mean maternal self‐confidence was 3.9 units (SD 0.7) n = 20

The mean maternal self‐confidence in the artificial milk group was 0.1 units higher on a 5‐point scale (95% CI 0.34 lower to 0.54 higher)

39
(1 RCT)

⊕⊕⊝⊝
LOW 1, 2, 6

Modified breastfeeding self‐efficacy score at 1 week. Items rated on a scale from 1 (“Strongly Disagree”) to 5 (“Strongly Agree”) with higher scores associated with more breastfeeding self‐efficacy

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Control group had low adherence to the study protocol (‐1).

2 We are unsure of the impact of the recruitment of only infants with greater than or equal to 5% weight loss as 5% is within normal expected range.

3 Wide confidence intervals crossing the line of no effect and small sample size (‐1).

4 1 trial had baseline imbalances in multiparity.

5 Evidence based on small sample size (‐1).

6 Confidence intervals crossing the line of no difference and small sample size (‐1).

7 1 trial with quasi‐random sequence generation, baseline imbalances for family history of allergy, 1 infant was changed from its allocated group due to family history of allergy, unclear if exclusive breastfeeding group received water or colostrum in the first 48 hours, high number of outcome assessors working independently and diagnosis of allergy was based on clinical criteria with no diagnostic testing

Figures and Tables -
Summary of findings for the main comparison. Non‐exclusive breastfeeding (artificial milk) versus exclusive breastfeeding
Summary of findings 2. Non‐exclusive breastfeeding (water or glucose water) versus exclusive breastfeeding

Non‐exclusive breastfeeding (water or glucose water) versus exclusive breastfeeding

Patient or population: healthy breastfeeding full‐term infants
Setting: hospital setting in Spain and UK
Intervention: non‐exclusive breastfeeding infants (water or glucose water)
Comparison: exclusive breastfeeding infants

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with exclusive breastfeeding infants

Risk with non‐exclusive breastfeeding infants (water)

Any breastfeeding at 12 weeks

Study population

RR 0.68
(0.53 to 0.87)

170
(1 RCT)

⊕⊕⊝⊝
LOW 1, 2

Estimated from the graph the percentage of mothers breastfeeding at each time period (see Table 1).

747 per 1000

508 per 1000
(396 to 650)

Hypoglycaemia episodes at 12 hours of life (glycaemia < 2.2 mmol/L)

Study population

RR 0.07 (0.00 to 1.20)

170
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1, 3, 4

Trialists used a cut‐off point as serum glucose less than 2.2 mmol/L whereas some researchers define a lower cut‐off level (1.7 mmol/L). Trialists report there was no case of serum glucose levels under 1.7 mmol/L in either of the 2 groups and no cases presented hypoglycaemic symptoms.

80 per 1000

6 per 1000
(0 to 97)

Hypoglycaemia episodes at 24 hours of life (glycaemia < 2.2 mmol/L)

Study population

RR 1.57
(0.27 to 9.17)

170
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1, 3, 4

Trialists used a cut‐off point as serum glucose less than 2.2 mmol/L whereas some researchers define a lower cut‐off level (1.7 mmol/L). Trialists report there was no case of serum glucose levels under 1.7 mmol/L in either of the 2 groups and no cases presented hypoglycaemic symptoms.

23 per 1000

36 per 1000
(6 to 211)

Weight change (loss) (g) at 48 hours

The mean weight loss (g) at 48 hours was 197.8 g (SD 73.2)

Infants with additional fluids (water) were on average (MD) 32.5 g heavier (less weight lost) (CI 12.91 g heavier to 52.09 g heavier)

170
(1 RCT)

⊕⊕⊝⊝
LOW 1, 2

This mean difference of 32.5 g is not clinically meaningful.

Weight change (loss) (g) at 72 hours

The mean weight loss (g) at 72 hours was 141.9 g (SD 89.1)

Infants with additional fluids (water) were on average (MD) 3 g lighter (more weight lost) (CI 26.83 g lighter to 20.83 heavier)

170
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1, 3

Weight loss (%) day 3

(percentage of birthweight)

The mean weight loss (%) day 3 was 6% of birthweight

Infants with additional fluids (water) lost on average (MD) 1.03% less of their birthweight (CI 2.24% less to 0.18% more weight lost)

47
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1, 3

We combined the glucose and water supplement arms of the Nicoll 1982 trial.

Weight loss (%) day 5

(percentage of birthweight)

The mean weight loss (%) day 5 was 4.3% of birthweight

Infants with additional fluids (water) lost on average (MD) 0.2% less of their birthweight (CI 0.86% less to 0.46% more weight lost)

47
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1, 3

We combined the glucose and water supplement arms of the Nicoll 1982 trial.

Confidence in breastfeeding (maternal or of those influencing the mother)

This outcome was not reported.

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; MD: mean difference; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 1 trial with no information on sequence generation or allocation concealment (‐1).

2 Evidence based on small sample size (‐1).

3 Wide confidence intervals crossing the line of no effect and small sample size (‐2).

4 Few events

Figures and Tables -
Summary of findings 2. Non‐exclusive breastfeeding (water or glucose water) versus exclusive breastfeeding
Summary of findings 3. Non‐exclusive breastfeeding (foods) versus exclusive breastfeeding

Non‐exclusive breastfeeding (foods) versus exclusive breastfeeding

Patient or population: healthy breastfeeding full‐term infants
Setting:home setting in Honduras, Iceland and the UK
Intervention: non‐exclusive breastfeeding infants (foods)
Comparison: exclusive breastfeeding infants

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with Exclusive breastfeeding infants

Risk with non‐exclusive breastfeeding infants (foods)

Duration of breastfeeding (at different time points)

This outcome was not reported in a format that could be analysed.

Fever (% of days) ‐ 4 to 6 months

The mean fever (% of days) ‐ 4 to 6 months was 8% days (SD 7.2)

Infants with additional foods had a fever on average 0.7% of days lower (CI 3.4% fewer to 2% more days)

119
(1 RCT)

⊕⊕⊝⊝
LOW 1, 2

“Food allergy” to 1 or more foods between 1 to 3 years of age

Study population

RR 0.80
(0.51 to 1.25)

1162
(1 RCT)

⊕⊕⊕⊝
MODERATE 2

There was low adherence to the protocol in the intervention group

71 per 1000

56 per 1000
(36 to 88)

Visible eczema at 12‐month visit stratified by visible eczema at enrolment

Study population

RR 0.86
(0.51 to 1.44)

284
(1 RCT)

⊕⊕⊕⊝
MODERATE 2

There was low adherence to the protocol in the intervention group

182 per 1000

156 per 1000
(93 to 262)

Food protein enterocolitis syndrome positive response to challenge (number of children)

Study population

RR 2.00
(0.18 to 22.04)

1303
(1 RCT)

⊕⊕⊕⊝
MODERATE 2

There was low adherence to the protocol in the intervention group

2 per 1000

3 per 1000
(0 to 34)

Weight change (gain) (g) ‐ 4 to 6 months

The mean weight change (gain) (g) at 4 to 6 months was 1054 g

Infants with additional foods gained on average (MD) 39.48 g less weight (CI 128.43 g less to 49.48 g more weight gain)

260
(2 RCTs)

⊕⊕⊝⊝
LOW 1 2

Weight change (z score)

as standard deviations of an overall population distribution of infant weight gain at 4 ‐ 6 months

The mean weight change (z score) was 0.01 standard deviations less weight gained

The mean weight change for infants with additional foods was 0.01 standard deviations less weight gained (0.15 standard deviations less weight gained to 0.13 standard deviations more weight gained)

100
(1 RCT)

⊕⊕⊕⊝
MODERATE 3

The differences in weight change from 4 to 6 months are negligible between the groups

Confidence in breastfeeding (maternal or of those influencing the mother)

This outcome was not reported in a format that could be analysed.

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; MD: mean difference; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Quasi‐random sequence generation (by week of birth) (‐1).

2 Wide confidence interval crossing the line of no effect and small sample size (‐1).

3 Estimate based on small sample size (‐1).

Figures and Tables -
Summary of findings 3. Non‐exclusive breastfeeding (foods) versus exclusive breastfeeding
Table 1. Martin‐Calama 1997. Primary outcome: breastfeeding duration

% of mothers who continued either exclusive or partial breastfeeding

Exclusive breastfeeding on day 1‐3 group (non‐glucose water) (n = 87)

Glucose water on day 1‐3 (n = 83)

At 4 weeks

93%

77%

At 8 weeks

81%

64%

At 12 weeks

75%

51%

At 16 weeks

67%

43%

At 20 weeks

57%

40%

These figures were estimated from a graph (Figure 2) on page 212 of the Martin‐Calama 1997 paper.

Figures and Tables -
Table 1. Martin‐Calama 1997. Primary outcome: breastfeeding duration
Comparison 1. Non‐exclusive breastfeeding infants (artificial milk) versus exclusive breastfeeding infants

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Breastfeeding duration Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Any breastfeeding at discharge

1

100

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.97, 1.08]

1.2 Exclusive breastfeeding in 24 hours prior to discharge

1

100

Risk Ratio (M‐H, Fixed, 95% CI)

1.11 [1.00, 1.24]

1.3 Exclusive breastfeeding at 1 week (previous 24 hours)

1

39

Risk Ratio (M‐H, Fixed, 95% CI)

1.71 [1.09, 2.68]

1.4 Exclusive breastfeeding at 3 months (previous 24 hours)

2

138

Risk Ratio (M‐H, Fixed, 95% CI)

1.43 [1.15, 1.77]

1.5 Any breastfeeding at 3 months

2

137

Risk Ratio (M‐H, Fixed, 95% CI)

1.21 [1.05, 1.41]

2 Allergy symptoms Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Infants with allergy symptoms at 18 months of age

1

207

Risk Ratio (M‐H, Fixed, 95% CI)

0.56 [0.35, 0.91]

3 Incidence of fever Show forest plot

1

38

Risk Ratio (M‐H, Fixed, 95% CI)

1.06 [0.83, 1.36]

4 Maternal self‐confidence ‐ Modified breastfeeding self‐efficacy score at 1 week Show forest plot

1

39

Mean Difference (IV, Fixed, 95% CI)

0.10 [‐0.34, 0.54]

5 Phototherapy in hospital or home Show forest plot

1

100

Risk Ratio (M‐H, Fixed, 95% CI)

0.33 [0.01, 7.99]

Figures and Tables -
Comparison 1. Non‐exclusive breastfeeding infants (artificial milk) versus exclusive breastfeeding infants
Comparison 2. Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Breastfeeding duration Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Any breastfeeding at 4 weeks

1

170

Risk Ratio (M‐H, Fixed, 95% CI)

0.83 [0.73, 0.94]

1.2 Any breastfeeding at 8 weeks

1

170

Risk Ratio (M‐H, Fixed, 95% CI)

0.79 [0.65, 0.96]

1.3 Any breastfeeding at 12 weeks

1

170

Risk Ratio (M‐H, Fixed, 95% CI)

0.68 [0.53, 0.87]

1.4 Any breastfeeding at 16 weeks

1

170

Risk Ratio (M‐H, Fixed, 95% CI)

0.65 [0.49, 0.87]

1.5 Any breastfeeding at 20 weeks

1

170

Risk Ratio (M‐H, Fixed, 95% CI)

0.69 [0.50, 0.95]

2 Maximum temperature (ºC) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

2.1 At 72 hours

1

170

Mean Difference (IV, Fixed, 95% CI)

‐0.10 [‐0.19, ‐0.01]

3 Minimum temperature (ºC) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

3.1 At 72 hours

1

170

Mean Difference (IV, Fixed, 95% CI)

‐0.10 [‐0.18, ‐0.02]

4 Episodes of hypoglycaemia (glycaemia < 2.2 mmol/L) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4.1 At 6 hours of life

1

170

Risk Ratio (M‐H, Fixed, 95% CI)

0.42 [0.08, 2.10]

4.2 At 12 hours of life

1

170

Risk Ratio (M‐H, Fixed, 95% CI)

0.07 [0.00, 1.20]

4.3 At 24 hours of life

1

170

Risk Ratio (M‐H, Fixed, 95% CI)

1.57 [0.27, 9.17]

4.4 At 48 hours of life

1

170

Risk Ratio (M‐H, Fixed, 95% CI)

0.35 [0.04, 3.29]

5 Mean capillary blood glucose levels of infants (mmol/L) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 At 6 hours of life

1

170

Mean Difference (IV, Random, 95% CI)

0.29 [0.02, 0.56]

5.2 At 12 hours of life

1

170

Mean Difference (IV, Random, 95% CI)

0.47 [0.24, 0.70]

5.3 At 24 hours of life

1

170

Mean Difference (IV, Random, 95% CI)

0.34 [0.08, 0.60]

5.4 At 48 hours of life

1

170

Mean Difference (IV, Random, 95% CI)

0.24 [‐0.03, 0.51]

6 Weight change (loss) (g) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

6.1 At 6 hours of life

1

170

Mean Difference (IV, Fixed, 95% CI)

‐7.0 [‐13.24, ‐0.76]

6.2 At 12 hours of life

1

170

Mean Difference (IV, Fixed, 95% CI)

‐11.5 [‐21.29, ‐1.71]

6.3 At 24 hours of life

1

170

Mean Difference (IV, Fixed, 95% CI)

‐13.40 [‐26.37, ‐0.43]

6.4 At 48 hours of life

1

170

Mean Difference (IV, Fixed, 95% CI)

‐32.5 [‐52.09, ‐12.91]

6.5 At 72 hours of life

1

170

Mean Difference (IV, Fixed, 95% CI)

3.0 [‐20.83, 26.83]

7 Weight loss (%) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

7.1 Day 3

1

47

Mean Difference (IV, Fixed, 95% CI)

‐1.03 [‐2.24, 0.18]

7.2 Day 5

1

47

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐0.86, 0.46]

8 Maximum serum bilirubin levels umol/L Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

8.1 Day 6

1

47

Mean Difference (IV, Fixed, 95% CI)

18.84 [‐1.35, 39.03]

Figures and Tables -
Comparison 2. Non‐exclusive breastfeeding infants (water) versus exclusive breastfeeding infants
Comparison 3. Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Fever (% of days) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

1.1 4 to 6 months

1

119

Mean Difference (IV, Fixed, 95% CI)

‐0.70 [‐3.40, 2.00]

2 Cough (% of days) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

2.1 At 4 to 6 months

1

119

Mean Difference (IV, Fixed, 95% CI)

3.10 [‐4.52, 10.72]

3 Congestion (% of days) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

3.1 At 4 to 6 months

1

119

Mean Difference (IV, Fixed, 95% CI)

3.60 [‐3.41, 10.61]

4 Nasal discharge (% of days) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

4.1 At 4 to 6 months

1

119

Mean Difference (IV, Fixed, 95% CI)

4.20 [‐1.13, 9.53]

5 Hoarseness (% of days) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

5.1 At 4 to 6 months

1

119

Mean Difference (IV, Fixed, 95% CI)

0.10 [‐1.84, 2.04]

6 “Food allergy” to one or more foods between 1‐3 years of age Show forest plot

1

1162

Risk Ratio (M‐H, Fixed, 95% CI)

0.80 [0.51, 1.25]

7 Visible eczema at 12‐month visit stratified by visible eczema at enrolment Show forest plot

1

284

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.51, 1.44]

8 Food protein enterocolitis syndrome positive response to challenge (number of children) Show forest plot

1

1303

Risk Ratio (M‐H, Fixed, 95% CI)

2.00 [0.18, 22.04]

9 Weight change (gain) (g) Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

9.1 At 4 to 6 months

2

260

Mean Difference (IV, Fixed, 95% CI)

‐39.48 [‐128.43, 49.48]

10 Weight change (z score) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

10.1 4 to 6 months

1

100

Mean Difference (IV, Fixed, 95% CI)

‐0.01 [‐0.15, 0.13]

Figures and Tables -
Comparison 3. Non‐exclusive breastfeeding infants (foods) versus exclusive breastfeeding infants