Fat supplementation of human milk for promoting growth in preterm infants

Emma A Amissah; Julie Brown; Jane E Harding

doi:10.1002/14651858.CD000341.pub2

母乳添加脂肪補充劑促進早產兒生長

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References

References to studies included in this review

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excluded studies
additional references
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Polberger SK, Axelsson IA, Räihä NC. Growth of very low birth weight infants on varying amounts of human milk protein. Pediatric Research 1989;25(4):414‐9. [DOI: 10.1203/00006450‐198904000‐00022; PUBMED: 2726319]

Polberger SK, Axelsson IE, Räihä NC. Amino acid concentrations in plasma and urine in very low birth weight infants fed protein‐unenriched or human milk protein‐enriched human milk. Pediatrics 1990;86(6):909‐15. [PUBMED: 2251029]

Polberger SK, Fex GA, Axelsson IE, Räihä NC. Eleven plasma proteins as indicators of protein nutritional status in very low birth weight infants. Pediatrics 1990;86(6):916‐21. [PUBMED: 2251030]

References to studies excluded from this review

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included studies
additional references
other published versions

Fewtrell MS. Does early nutrition program later bone health in preterm infants?. American Journal of Clinical Nutrition 2011;94(6 Suppl):1870S‐3S. [DOI: 10.3945/ajcn.110.000844; PUBMED: 21543543]

Lauterbach R. A supplementation of DHA and AA to human milk‐fed VLBW infants has no significant cognitive improvement or measurable neuroanatomical effects when evaluated at 8 years of age. Evidence‐based Medicine 2015;20(5):177. [DOI: 10.1136/ebmed‐2015‐110242; PUBMED: 26282164]

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Rönnholm KA, Simell O, Siimes MA. Human milk protein and medium‐chain triglyceride oil supplementation of human milk: plasma amino acids in very low‐birth‐weight infants. Pediatrics 1984;74(5):792‐9. [PUBMED: 6387613]

Additional references

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Arslanoglu S, Corpeleijn W, Moro G, Braegger C, Campoy C, Colomb V, et al. ESPGHAN Committee on Nutrition. Donor human milk for preterm infants: current evidence and research directions. Journal of Pediatric Gastroenterology and Nutrition 2013;57(4):535‐42. [DOI: 10.1097/MPG.0b013e3182a3af0a; PUBMED: 24084373]

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References to other published versions of this review

Jump to:

included studies
excluded studies
additional references

Kuschel CA, Harding JE. Fat supplementation of human milk for promoting growth in preterm infants. Cochrane Database of Systematic Reviews 1999, Issue 3. [DOI: 10.1002/14651858.CD000341]

Kuschel CA, Harding JE. Fat supplementation of human milk for promoting growth in preterm infants. Cochrane Database of Systematic Reviews 2000, Issue 1. [DOI: 10.1002/14651858.CD000341]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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excluded studies

Polberger 1989

Methods	Parallel randomised controlled trial in two neonatal units.
Participants	Inclusion criteria: birth weight < 1500 g, appropriate‐for‐gestational‐age, tolerance of complete enteral feeding (170 mL/kg/day), no obvious disease or major malformations, no oxygen therapy, and informed parental consent and acceptance of a blind trial Exclusion criteria: not stated Setting: two neonatal units of the University of Lund in Malmo and Lund Timing: not stated
Interventions	1.0 g of human milk fat per 100 mL unpasteurised human milk (maternal or term banked donor) (n = 7) versus unsupplemented human milk (n = 7). Intervention ceased when the infant reached approximately 2200 g or was breastfed. All infants were supplemented with additional vitamins, calcium lactate (30 mg/kg/day) and sodium phosphate (20 mg/kg/day). From 4 weeks, 2 mg/kg/day elemental iron was given to all infants.
Outcomes	The outcomes were not specified as primary or secondary but the following were assessed: short‐term growth parameters (weight, crown‐heel length, occipito‐frontal head circumference), intake of protein, fat, carbohydrates, energy, and electrolytes (sodium, potassium, calcium).
Notes	Conflicts of interest: no details Source of Funding: supported in part by the Swedish Medical Research Council, Grant No. B85‐ I'IX‐06259, and Stiftelsen Saniarite This study had four arms: unsupplemented versus supplemented with protein versus supplemented with fat versus supplemented with fat and protein. The analyses of the protein and combined fat and protein arms are discussed in other reviews on multi‐component and protein supplementation, respectively (Brown 2016; Kuschel 2000). Of the 34 infants enrolled in the study, 6 were withdrawn following randomisation for apnoea (n = 2), intolerance to accepting the fixed volume (n = 3) and need for intravenous therapy (n = 1).
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No details
Allocation concealment (selection bias)	Unclear risk	The study used closed envelopes without specifying if they were opaque or not.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	The study was stated to be double‐blinded, but who was blinded was not specified
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	It was not specified whether outcome assessors were blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The missing data (i.e. from 6 infants) was less than 20%. They were excluded for the following reasons: 2 had apnoea, 3 developed feeding intolerance, and 1 needed intravenous therapy. However, the authors did not report whether there were any differences between infants excluded and included in the study.
Selective reporting (reporting bias)	Unclear risk	No details were given as to which were primary and secondary outcomes, and no protocol was viewed to clarify whether the outcomes reported were the only ones collected.
Other bias	Unclear risk	The authors stated 'there was a difference in sex distribution between the groups and later analyses confirmed that this difference had no implications on the results'. However, no further details were provided as to how this conclusion was reached.

Characteristics of excluded studies [ordered by study ID]

Jump to:

included studies

Study	Reason for exclusion
Fewtrell 2011	Irrelevant intervention
Lauterbach 2015	A commentary of a trial with irrelevant intervention
Makrides 1997	Fat supplementation of maternal diet of lactating mothers
Rönnholm 1984	Unable to extract data for infants supplemented with fat alone

Data and analyses

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Comparison 1. Fat supplementation vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Growth ‐ weight Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.1 Comparison 1 Fat supplementation vs control, Outcome 1 Growth ‐ weight.
1.1 Weight gain (g/kg/day)	1	14	Mean Difference (IV, Fixed, 95% CI)	0.60 [‐2.36, 3.56]
1.2 Weight at end of study (g)	1	14	Mean Difference (IV, Fixed, 95% CI)	40.0 [‐258.62, 338.62]
2 Growth ‐ length Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.2 Comparison 1 Fat supplementation vs control, Outcome 2 Growth ‐ length.
2.1 Length gain (cm/week)	1	14	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.08, 0.28]
3 Growth ‐ head circumference Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.3 Comparison 1 Fat supplementation vs control, Outcome 3 Growth ‐ head circumference.
3.1 Head growth (cm/week)	1	14	Mean Difference (IV, Fixed, 95% CI)	0.15 [‐0.07, 0.37]
4 Feeding intolerance Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.4 Comparison 1 Fat supplementation vs control, Outcome 4 Feeding intolerance.

Figure 1

81, Study flow diagram: review update

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

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

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Analysis 1.1

Comparison 1 Fat supplementation vs control, Outcome 1 Growth ‐ weight.

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Analysis 1.2

Comparison 1 Fat supplementation vs control, Outcome 2 Growth ‐ length.

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Analysis 1.3

Comparison 1 Fat supplementation vs control, Outcome 3 Growth ‐ head circumference.

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Analysis 1.4

Comparison 1 Fat supplementation vs control, Outcome 4 Feeding intolerance.

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Summary of findings for the main comparison. Fat supplementation compared to control for promoting growth in preterm infants

Fat supplementation compared to control for promoting growth in preterm infants
Patient or population: preterm infants Setting: two neonatal units in Sweden Intervention: fat supplementation of human milk Comparison: unsupplemented human milk
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with control	Risk with Fat supplementation	Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
Growth ‐ weight ‐ weight gain (g/kg/day)	The mean weight gain in the unsupplemented human milk group was 15.3 g/kg/day.	MD 0.6 g/kg/day higher (2.4 lower to 3.6 higher)	‐	14 (1 RCT)	⊕⊝⊝⊝ Very low ^{1 2}
Growth ‐ length ‐ length gain (cm/week)	The mean length gain in the unsupplemented human milk group was 0.8 cm/week.	MD 0.1 cm/week higher (0.08 lower to 0.3 higher)	‐	14 (1 RCT)	⊕⊝⊝⊝ Very low ^{1 2}
Growth ‐ head circumference ‐ head growth (cm/week)	The mean head growth in the unsupplemented human milk group was 0.9 cm/week.	MD 0.2 cm/week higher (0.07 lower to 0.4 higher)	‐	14 (1 RCT)	⊕⊝⊝⊝ Very low ^{1 2}
Neurodevelopmental outcomes	‐	‐	‐	‐	‐	None of the included studies reported on neurodevelopmental outcomes.
Duration of hospital admission (days)	‐	‐	‐	‐	‐	None of the included studies reported on duration of hospital admission.
Feeding intolerance	0 per 1000	0 per 1000 (0 to 0)	RR 3.00 (0.1 to 64.3)	16 (1 RCT)	⊕⊝⊝⊝ Very low ^{1 3}	.
Necrotising enterocolitis	‐	‐	‐	‐	‐	None of the included studies reported on necrotising enterocolitis.
*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; OR: odds 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 Risk of bias: most of the trials lacked methodological details so that we were unable to judge risk of bias. This could have an impact on assessment of growth parameters and possibly the estimate of effect. Single trial. We downgraded one level. ² Imprecision: few patients and wide confidence intervals, which included meaningful benefit and harm. Single trial. We downgraded two levels. ³ Imprecision: few patients, few events and wide confidence intervals, which include meaningful benefit and harm. Single trial. We downgraded two levels.

Summary of findings for the main comparison. Fat supplementation compared to control for promoting growth in preterm infants

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Comparison 1. Fat supplementation vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Growth ‐ weight Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.1 Weight gain (g/kg/day)	1	14	Mean Difference (IV, Fixed, 95% CI)	0.60 [‐2.36, 3.56]
1.2 Weight at end of study (g)	1	14	Mean Difference (IV, Fixed, 95% CI)	40.0 [‐258.62, 338.62]
2 Growth ‐ length Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 Length gain (cm/week)	1	14	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.08, 0.28]
3 Growth ‐ head circumference Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

3.1 Head growth (cm/week)	1	14	Mean Difference (IV, Fixed, 95% CI)	0.15 [‐0.07, 0.37]
4 Feeding intolerance Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

Comparison 1. Fat supplementation vs control

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References

References to studies included in this review

Polberger 1989 {published data only}

References to studies excluded from this review

Fewtrell 2011 {published data only}

Lauterbach 2015 {published data only}

Makrides 1997 {published data only}

Rönnholm 1984 {published data only}

Additional references

Arslanoglu 2013

Berseth 2014

Bhatia 2016

Brown 2016

Chang 2012

Choi 2016

Delplanque 2015

Deshpande 2011

Fenton 2013

Geddes 2013

Georgieff 2005

GRADEpro GDT [Computer program]

Hadley 2016

Higgins 2017

Howles 1999

Innis 2003

Innis 2014

Isaacs 2009

Kenner 2014

Koletzko 2014

Kuschel 2000

Lapillonne 2014

Li 2013

Lindquist 2010

Longo 2016

Martin 2015

Moon 2016

Patel 2016

Peila 2016

Pereira‐da‐Silva 2008

Review Manager 2014 [Computer program]

Robinson 2017

Schünemann 2013

Section on Breastfeeding 2012

Stocks 1985

Su 2014

Underwood 2013

Vieira 2011

WHO 1995

Yang 2013

Younge 2017

References to other published versions of this review

Kuschel 1999

Kuschel 2000

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Data and analyses

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