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Trial reportEuropean journal of pediatrics2024

Influence of bovine lactoferrin on feeding intolerance and intestinal permeability in preterm infants: a randomized controlled trial.

Nermeen Ellakkany, Hesham Abdel-Hady, Ahmed Mahfouz Eita, Youssef M Mosaad, Ahmed Megahed

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of pediatrics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04738058 (Influence of Bovine Lactoferrin on Feeding Intolerance and Intestinal Permeability in Preterm Neonates), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT04738058 phase1unknown statusnot on this map

Influence of Bovine Lactoferrin on Feeding Intolerance and Intestinal Permeability in Preterm Neonates: a Randomized Controlled Trial

TypeinterventionalSponsorMansoura University Children HospitalRan2020 to 2022Enrolled60ConditionsFeeding Intolerance in Preterm, Intestinal Permeability in PretermArmsBovine Lactoferrin Supplement, placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
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

5 authors.

Nermeen EllakkanyFaculty of Medicine, Horus University - Egypt, Damietta, Egypt. Nermeen.ellakany@gmail.com.
Hesham Abdel-HadyFaculty of Medicine, Mansoura University, Mansoura, Egypt.
Ahmed Mahfouz EitaFaculty of Medicine, Mansoura University, Mansoura, Egypt.
Youssef M MosaadFaculty of Medicine, Mansoura University, Mansoura, Egypt.
Ahmed MegahedFaculty of Medicine, Mansoura University, Mansoura, Egypt.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectsPreterm infants are at an increased risk of developing feeding intolerance (FI) due to the functional immaturity of their gastrointestinal tract. Recent studies and meta-analyses have shown a significant role of bovine lactoferrin (LF) in the management of feeding intolerance and sepsis. This study aimed to assess the effects of oral bovine LF supplementation on FI in preterm infants (26-34 weeks gestational age) and its effect on intestinal permeability measured by serum zonulin concentrations.

methodsA randomized controlled double-blind interventional pilot study was conducted in the Neonatal Intensive Care Unit (NICU) of Mansoura University. Sixty preterm neonates with FI were included in the study and were randomly assigned into two groups: lactoferrin group (100 mg/day bovine LF for 4 weeks or until discharge) and control group.

resultsThe time needed to achieve full enteral feeding of sixty preterm infants (26-34 weeks gestational age) (9 vs. 15 days, P = 0.001) was significantly shorter and serum zonulin concentrations at end of the trial or discharge (3.38 vs. 5.49 ng/ml, P = 0.04) were significantly lower in the lactoferrin group compared with the control group.

conclusionOral bovine lactoferrin given to preterm infants (26-34 weeks gestational age) is associated with improvement of feeding intolerance and decreased intestinal permeability.

trial registrationThis study was registered at clinical trials.gov with ID (NCT04738058) at 2 March 2021.

Indexed as

HaptoglobinsInfant, PrematureLactoferrinPermeabilityAdministration, OralAnimalsCattleCholera ToxinDouble-Blind MethodEnteral NutritionFemaleFood IntoleranceHumansInfant, NewbornInfant, Premature, DiseasesIntensive Care Units, NeonatalCholera ToxinHaptoglobinsLactoferrinProtein PrecursorszonulinBovine lactoferrinFeeding intolerancePreterm infants

Identifiers

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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.