Evidence map›Paper›PMID 22534258›Full record

Trial reportBMC research notes2012

An exclusive human milk-based diet in extremely premature infants reduces the probability of remaining on total parenteral nutrition: a reanalysis of the data.

Heli Ghandehari, Martin L Lee, David J Rechtman, H2MF Study Group

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC research notes, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
2.5field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00506584 nacompletednot on this map

A Randomized Study of Human Milk-Based Versus Bovine-based Nutrition for Very Low Birth Weight Pre-Term Infants

TypeinterventionalSponsorProlacta BioscienceRan2007 to 2008Enrolled260ConditionsInfant, Very Low Birth WeightArmsPasteurized human milk and pasteurized human milk fortifier, Human milk fortifier (bovine-based), pre-term formula, Pre-term/term formula
NCT03839173 naunknown statusnot on this mapstarted 2019, after this paper: background citation

Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet

TypeinterventionalSponsorAugusta UniversityRan2019 to 2020Enrolled51ConditionsPremature Infant, Breast Milk ExpressionArmsHuman milk based human milk fortifier
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Beyond Necrotizing Enterocolitis: Other Clinical Advantages of an Exclusive Human Milk Diet.Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine
    Trial
  7. Article
  8. Review of Preterm Human-Milk Nutrient Composition.Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition · 2021
    Review
  9. Observational
  10. Article
  11. Review
  12. Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk-Based Diet.Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine · 2016
    Article
  13. Aggressive Nutrition of the Preterm Infant.Current pediatrics reports · 2013
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Heli GhandehariUCLA School of Public Health, 405 Hilgard Avenue, Los Angeles, CA 90024, USA.
Martin L Lee
David J Rechtman
H2MF Study Group
UCLA Health · USTRIA Bioscience (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe have previously shown that an exclusively human milk-based diet is beneficial for extremely premature infants who are at risk for necrotizing enterocolitis (NEC). However, no significant difference in the other primary study endpoint, the length of time on total parenteral nutrition (TPN), was found. The current analysis re-evaluates these data from a different statistical perspective considering the probability or likelihood of needing TPN on any given day rather than the number of days on TPN. This study consisted of 207 premature infants randomized into three groups: one group receiving a control diet of human milk, formula and bovine-based fortifier ("control diet"), and the other two groups receiving only human milk and human milk-based fortifier starting at different times in the enteral feeding process (at feeding volumes of 40 or 100 mL/kg/day; "HM40" and "HM100", respectively). The counting process Cox proportional hazards survival model was used to determine the likelihood of needing TPN in each group.

resultsThe two groups on the completely human-based diet had an 11-14 % reduction in the likelihood of needing nutrition via TPN when compared to infants on the control diet (p = 0.0001 and p = 0.001, respectively for the HM40 and HM100 groups, respectively). This was even more pronounced if the initial period of TPN was excluded (p < 0.0001 for both the HM40 and HM100 groups).

conclusionsA completely human milk-based diet significantly reduces the likelihood of TPN use for extremely premature infants when compared to a diet including cow-based products. This likelihood may be reduced even further when the human milk fortifier is initiated earlier in the feeding process.

trial registrationThis study was registered at http://www.clinicaltrials.gov reg. # NCT00506584.

Indexed as

Enteral NutritionInfant, Extremely PrematureInfant FormulaInfant Nutritional Physiological PhenomenaMilk, HumanParenteral NutritionAustriaBirth WeightGestational AgeHumansInfant, Extremely Low Birth WeightInfant, NewbornInfant, Small for Gestational AgeInfant, Very Low Birth WeightLikelihood FunctionsProportional Hazards Models

Identifiers

PMID22534258
PMCPMC3527141
OpenAlexW2049386149

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.