High versus standard volume enteral feeds to promote growth in preterm or low birth weight infants

Thangaraj Abiramalatha; Niranjan Thomas; Sivam Thanigainathan

doi:10.1002/14651858.CD012413.pub3

Cochrane Database of Systematic Reviews

Alimentación enteral a un volumen alto versus estándar para promover el crecimiento en lactantes prematuros o con bajo peso al nacer

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DOI:

https://doi.org/10.1002/14651858.CD012413.pub3 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

12 marzo 2021see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Neonatología

Copyright:

Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Contraer

Autores

Thangaraj Abiramalatha

Correspondencia a: Neonatology, Sri Ramachandra Institute of Higher Education and Research, Chennai, India

[email protected]
Niranjan Thomas

Neonatology, Joan Kirner Women's and Children's at Sunshine Hospital, Western Health, St Albans, Australia
Sivam Thanigainathan

Neonatology, All India Institute of Medical Sciences, Jodhpur, India

Contributions of authors

TA (along with NT and ST) revised the previous protocol (Abiramalatha 2016). TA, NT and ST revised the previous published review (Abiramalatha 2017).

For this review update, TA and ST screened search outputs, assessed study eligibility, and extracted and synthesised data. TA and ST assessed risk of bias across key domains and undertook GRADE assessment. All review authors revised the final review update.

Sources of support

Internal sources

No sources of support supplied

External sources

National Institute for Health Research, UK

This report is independent research funded by a UK National Institute of Health Research Grant (NIHR) Cochrane Programme Grant (13/89/12). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR, or the UK Department of Health.
The Gerber Foundation, USA

Editorial support for this review, as part of a suite of preterm nutrition reviews, has been provided by a grant from The Gerber Foundation. The Gerber Foundation is a separately endowed, private, 501(c)(3) foundation not related to Gerber Products Company in any way.
Vermont Oxford Network, USA

Cochrane Neonatal Reviews are produced with support from Vermont Oxford Network, a worldwide collaboration of health professionals dedicated to providing evidence‐based care of the highest quality for newborn infants and their families.

Declarations of interest

TA has no interest to declare.

NT was the principal investigator in one study included in this review (Thomas 2012). However, TA performed the 'Risk of bias' assessment and data extraction for the trial. NT received no funding for Thomas 2012.

ST has no interest to declare.

Core editorial and administrative support for this review has been provided by a grant from The Gerber Foundation. The Gerber Foundation is a separately endowed, private foundation, independent from the Gerber Products Company. The grantor has no input on the content of the review or the editorial process (see Sources of support).

Acknowledgements

We would like to thank Cochrane Neonatal: Colleen Ovelman, Managing Editor, Jane Cracknell, Assistant Managing Editor, Roger Soll, Co‐coordinating editor, and William McGuire, Co‐coordinating Editor, who provided editorial and administrative support.

Melissa Harden, Information Specialist, Centre for Reviews and Dissemination, York, UK, designed and ran the literature searches.

Sarah Hodgkinson and William McGuire peer reviewed and offered feedback for this update.

We are grateful to Drs Carl Kuschel and Colm Travers for providing further data and details of their trials.

Version history

Published

Title

Stage

Authors

Version

2021 Mar 12

High versus standard volume enteral feeds to promote growth in preterm or low birth weight infants

Review

Thangaraj Abiramalatha, Niranjan Thomas, Sivam Thanigainathan

https://doi.org/10.1002/14651858.CD012413.pub3

2017 Sep 12

High versus standard volume enteral feeds to promote growth in preterm or low birth weight infants

Review

Thangaraj Abiramalatha, Niranjan Thomas, Vijay Gupta, Anand Viswanathan, William McGuire

https://doi.org/10.1002/14651858.CD012413.pub2

2016 Oct 21

High versus standard volumes of enteral feeds for preterm or low birth weight infants

Protocol

Thangaraj Abiramalatha, Niranjan Thomas, Vijay Gupta, Anand Viswanathan, William McGuire

https://doi.org/10.1002/14651858.CD012413

Differences between protocol and review

2020

We have done the following changes to the previous publication of the review (Abiramalatha 2017).

We compared high versus standard volume of 'fortified human milk or preterm formula' and 'unfortified human milk or term formula' in two separate comparisons in this updated review. The volume cut‐offs for high and standard volume feeds for each comparison were chosen based on the prevailing practice and nutritional requirements of preterm infants, as described in the background section.
The objectives of this updated review have been modified. In infants who were fed fortified human milk or preterm formula, high and standard volume feeds were defined as > 180 mL/kg/day and ≤ 180 mL/kg/day, respectively. In infants who were fed unfortified human milk or term formula, high and standard volume feeds were defined as > 200 mL/kg/day and ≤ 200 mL/kg/day, respectively.
Some of the outcomes of this review have been modified as follows:
- Changes to primary outcomes:
  - "Z‐scores of weight, length and head circumference" have been changed to "growth measures namely weight, length and head circumference, measured at a specified postmenstrual age prior to discharge" and this outcome was moved to secondary outcomes;
  - Growth measures following discharge from hospital to latest follow‐up: moved to secondary outcomes;
  - "Number of infants with feed intolerance: vomiting, excessive gastric residual volumes (defined by investigators), or abdominal distension that results in reduction or cessation of enteral feeding)" has been changed to "Proportion of infants with feed interruption episodes (lasting ≥ 12 hours)".
- We have added one new secondary outcome: Time to regain birth weight (days).
In subgroup analysis, "Very preterm (< 32 weeks' gestation) or VLBW (< 1500 grams) infants versus preterm infants born at between 32 and 36 weeks' gestation or with birth weight 1500 to 2499 grams": changed to "Based on gestational age: < 28 weeks, 28 to 31 weeks, ≥ 32 weeks and 2. Based on birth weight: < 1000 grams, 1000 to 1499 grams, ≥ 1500 grams".
We updated the 'Risk of bias' and the certainty of the evidence.
For the 2020 update, we developed a new search strategy. The previous search methods are available in Appendix 2.
We added new external sources of support.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans; Infant, Newborn;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

Updated study flow diagram.

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Figure 2

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

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Figure 3

Forest plot of comparison: 1 High versus standard volume of fortified human milk or preterm formula, outcome: 1.1 Weight gain during hospital stay (g/kg/day).

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Figure 4

Forest plot of comparison: 1 High versus standard volume of fortified human milk or preterm formula, outcome: 1.5 Necrotising enterocolitis.

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Figure 5

Forest plot of comparison: 1 High versus standard volume of fortified human milk or preterm formula, outcome: 1.8 Weight at a specified postmenstrual age (g).

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Figure 6

Forest plot of comparison: 1 High versus standard volume of fortified human milk or preterm formula, outcome: 1.10 Head circumference at a specified postmenstrual age (cm).

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Figure 7

Forest plot of comparison: 2 High versus standard volume of unfortified human milk or term formula, outcome: 2.1 Weight gain during hospital stay (g/kg/day).

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Analysis 1.1

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 1: Weight gain during hospital stay (g/kg/day)

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Analysis 1.2

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 2: Linear growth during hospital stay (cm/week)

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Analysis 1.3

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 3: Head growth during hospital stay (cm/week)

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Analysis 1.4

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 4: Extrauterine growth restriction at discharge

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Analysis 1.5

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 5: Necrotising enterocolitis

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Analysis 1.6

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 6: Feed interruption episodes

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Analysis 1.7

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 7: Time to regain birth weight (days)

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Analysis 1.8

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 8: Weight at a specified postmenstrual age (g)

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Analysis 1.9

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 9: Length at a specified postmenstrual age (cm)

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Analysis 1.10

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 10: Head circumference at a specified postmenstrual age (cm)

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Analysis 1.11

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 11: PDA requiring treatment

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Analysis 1.12

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 12: Chronic lung disease

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Analysis 1.13

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 13: All‐cause mortality before discharge

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Analysis 1.14

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 14: Duration of hospital stay (days)

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Analysis 1.15

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 15: Weight < 10th percentile at 12 months' corrected age

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Analysis 1.16

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 16: Length < 10th percentile at 12 months' corrected age

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Analysis 1.17

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 17: Head circumference < 10th percentile at 12 months' corrected age

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Analysis 1.18

Comparison 1: High versus standard volume of fortified human milk or preterm formula, Outcome 18: Neurodevelopmental impairment at 12 months' corrected age

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Analysis 2.1

Comparison 2: High versus standard volume of unfortified human milk or term formula, Outcome 1: Weight gain during hospital stay (g/kg/day)

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Analysis 2.2

Comparison 2: High versus standard volume of unfortified human milk or term formula, Outcome 2: Necrotising enterocolitis

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Analysis 2.3

Comparison 2: High versus standard volume of unfortified human milk or term formula, Outcome 3: Time to regain birth weight (days)

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Summary of findings 1. High compared to standard volume of fortified human milk or preterm formula in preterm or low birth weight infants

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
High compared to standard volume of fortified human milk or preterm formula in preterm or low birth weight infants
Patient or population: preterm or low birth weight infants Setting: neonatal intensive care unit (Australia and United States) Intervention: high volume feeds with fortified human milk or preterm formula Comparison: standard volume feeds with fortified human milk or preterm formula
Outcomes	Risk with standard volumes of fortified human milk or preterm formula	Risk with High volumes of fortified human milk or preterm formula	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Weight gain during hospital stay (g/kg/day) Follow‐up: Until discharge or 35‐36 weeks PMA	The mean weight gain during hospital stay varied from 16.5 to 17.9 g/kg/day	MD 2.58 higher (1.41 higher to 3.76 higher)	‐	271 (2 RCTs)	⊕⊕⊕⊝ MODERATE ¹	Probably improves weight gain during hospital stay
Linear growth during hospital stay (cm/week) Follow‐up: Until discharge or 35‐36 weeks PMA	The mean linear growth during hospital stay varied from 0.64 to 0.89 cm/week	MD 0.05 higher (0.02 lower to 0.13 higher)	‐	271 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}	May or may not improve linear growth during hospital stay
Head growth during hospital stay (cm/week) Follow‐up: Until discharge or 35‐36 weeks PMA	The mean head growth during hospital stay varied from 0.59 to 0.83 cm/week	MD 0.02 higher (0.04 lower to 0.09 higher)	‐	271 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}	May or may not improve linear growth during hospital stay
Extrauterine growth restriction at discharge Follow‐up: Until discharge	Study population		RR 0.71 (0.50 to 1.02)	271 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}	May or may not reduce extrauterine growth restriction at discharge
	312 per 1,000	222 per 1,000 (156 to 318)	RR 0.71 (0.50 to 1.02)	271 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1 2}
Necrotising enterocolitis Follow‐up: Until discharge	Study population		RR 0.74 (0.12 to 4.51)	283 (2 RCTs)	⊕⊝⊝⊝ VERY LOW ^{2 3}	Uncertainty regarding the effect on the risk of NEC
Necrotising enterocolitis Follow‐up: Until discharge	14 per 1,000	10 per 1,000 (2 to 62)	RR 0.74 (0.12 to 4.51)	283 (2 RCTs)	⊕⊝⊝⊝ VERY LOW ^{2 3}	Uncertainty regarding the effect on the risk of NEC
*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; PMA: Postmenstrual age; RR: Risk ratio
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: 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 certainty: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Downgraded one level for serious imprecision due to small sample size ² Downgraded one level for serious risk of bias due to lack of masking ³Downgraded by two levels for very serious imprecision due to small sample size and wide confidence interval

Summary of findings 1. High compared to standard volume of fortified human milk or preterm formula in preterm or low birth weight infants

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Summary of findings 2. High compared to standard volume of unfortified human milk or term formula in preterm or low birth weight infants

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
High compared to standard volume of unfortified human milk or term formula in preterm or low birth weight infants
Patient or population: preterm or low birth weight infants Setting: neonatal intensive care units (India) Intervention: high volume feeds with unfortified human milk or term formula Comparison: standard volume feeds with unfortified human milk or term formula
Outcomes	Risk with standard volume of unfortified human milk or term formula	Risk with High volumes of unfortified human milk or term formula	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Weight gain during hospital stay (g/kg/day) Follow‐up: Until babies reach 1700 g weight	The mean weight gain during hospital stay was 18.7 g/kg/day	MD 6.2 higher (2.71 higher to 9.69 higher)	‐	61 (1 RCT)	⊕⊕⊕⊝ MODERATE ¹	Probably improves weight gain during hospital stay
Linear growth (cm/week)	‐	see comment	‐	(0 studies)	‐	We found no data on this outcome.
Head growth (cm/week)	‐	see comment	‐	(0 studies)	‐	We found no data on this outcome.
Extrauterine growth restriction at discharge	Study population		‐	(0 studies)	‐	We found no data on this outcome.
Extrauterine growth restriction at discharge	see comment	see comment	‐	(0 studies)	‐	We found no data on this outcome.
Necrotising enterocolitis Follow‐up: Until discharge	Study population		RR 1.03 (0.07 to 15.78)	61 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{2 3}	Uncertainty regarding the effect on the risk of NEC
Necrotising enterocolitis Follow‐up: Until discharge	32 per 1,000	33 per 1,000 (2 to 509)	RR 1.03 (0.07 to 15.78)	61 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{2 3}	Uncertainty regarding the effect on the risk of NEC
*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 certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: 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 certainty: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Downgraded one level for serious imprecision due to small sample size ² Downgraded one level for serious risk of bias due to lack of masking ³ Downgraded two levels for very serious imprecision due to small sample size and wide confidence intervals

Summary of findings 2. High compared to standard volume of unfortified human milk or term formula in preterm or low birth weight infants

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Table 1. Typical energy and protein content of human milk or formula

Per 100 mL

Expressed breast milk

(EBM)

EBM

+ fortifier

Term formula

Preterm formula

Energy (kCal)

67

80

67

80

Protein (g)

1.5

2.0 to 2.3

1.5

2.0

Table 1. Typical energy and protein content of human milk or formula

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Comparison 1. High versus standard volume of fortified human milk or preterm formula

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Weight gain during hospital stay (g/kg/day) Show forest plot	2	271	Mean Difference (IV, Fixed, 95% CI)	2.58 [1.41, 3.76]

1.2 Linear growth during hospital stay (cm/week) Show forest plot	2	271	Mean Difference (IV, Fixed, 95% CI)	0.05 [‐0.02, 0.13]

1.3 Head growth during hospital stay (cm/week) Show forest plot	2	271	Mean Difference (IV, Fixed, 95% CI)	0.02 [‐0.04, 0.09]

1.4 Extrauterine growth restriction at discharge Show forest plot	2	271	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.50, 1.02]

1.5 Necrotising enterocolitis Show forest plot	2	283	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.12, 4.51]

1.6 Feed interruption episodes Show forest plot	1	217	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.12, 4.25]

1.7 Time to regain birth weight (days) Show forest plot	2	271	Mean Difference (IV, Fixed, 95% CI)	‐1.23 [‐2.36, ‐0.10]

1.8 Weight at a specified postmenstrual age (g) Show forest plot	2	271	Mean Difference (IV, Fixed, 95% CI)	152.10 [71.67, 232.53]

1.9 Length at a specified postmenstrual age (cm) Show forest plot	2	271	Mean Difference (IV, Fixed, 95% CI)	0.50 [‐0.04, 1.04]

1.10 Head circumference at a specified postmenstrual age (cm) Show forest plot	2	271	Mean Difference (IV, Fixed, 95% CI)	0.49 [0.15, 0.83]

1.11 PDA requiring treatment Show forest plot	2	271	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.28, 2.12]

1.12 Chronic lung disease Show forest plot	2	271	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.57, 1.81]

1.13 All‐cause mortality before discharge Show forest plot	2	283	Risk Ratio (M‐H, Fixed, 95% CI)	0.24 [0.01, 4.71]

1.14 Duration of hospital stay (days) Show forest plot	2	271	Mean Difference (IV, Fixed, 95% CI)	1.00 [‐3.54, 5.54]

1.15 Weight < 10th percentile at 12 months' corrected age Show forest plot	1	47	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.23, 2.15]

1.16 Length < 10th percentile at 12 months' corrected age Show forest plot	1	47	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.08, 1.55]

1.17 Head circumference < 10th percentile at 12 months' corrected age Show forest plot	1	47	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.01, 8.11]

1.18 Neurodevelopmental impairment at 12 months' corrected age Show forest plot	1	47	Risk Ratio (M‐H, Fixed, 95% CI)	0.52 [0.15, 1.84]

Comparison 1. High versus standard volume of fortified human milk or preterm formula

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Comparison 2. High versus standard volume of unfortified human milk or term formula

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Weight gain during hospital stay (g/kg/day) Show forest plot	1	61	Mean Difference (IV, Fixed, 95% CI)	6.20 [2.71, 9.69]

2.2 Necrotising enterocolitis Show forest plot	1	61	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.07, 15.78]

2.3 Time to regain birth weight (days) Show forest plot	1	61	Mean Difference (IV, Fixed, 95% CI)	‐0.50 [‐2.61, 1.61]

Comparison 2. High versus standard volume of unfortified human milk or term formula

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Alimentación enteral a un volumen alto versus estándar para promover el crecimiento en lactantes prematuros o con bajo peso al nacer

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Version history

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Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

PICO

PICO

Population

Intervention

Comparison

Outcome

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MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

PICO

PICO

Population

Intervention

Comparison

Outcome

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