Evidence map›Paper›PMID 25962930›Full record

Trial reportThe Journal of pediatrics2015

Randomized Clinical Trial of Preoperative Feeding to Evaluate Intestinal Barrier Function in Neonates Requiring Cardiac Surgery.

Sinai C Zyblewski, Paul J Nietert, Eric M Graham, Sarah N Taylor, Andrew M Atz, Carol L Wagner

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of pediatrics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01475357 (Intestinal Function in Neonates With Complex Congenital Heart Disease), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 25% 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.

NCT01475357 nacompletednot on this map

Intestinal Function in Neonates With Complex Congenital Heart Disease

TypeinterventionalSponsorMedical University of South CarolinaRan2011 to 2014Enrolled27ConditionsCongenital Heart Defects, Growth FailureArmsArm 1: NPO by mouth pre-operative, Arm 2: Fresh Breast Milk pre-operative
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Preoperative Feeding Neonates With Cardiac Disease.World journal for pediatric & congenital heart surgery · 2017
    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

6 authors at 1 institution in 1 country.

Sinai C ZyblewskiDivision of Pediatric Cardiology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC. Electronic address: chois@musc.edu.
Paul J NietertDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC.
Eric M GrahamDivision of Pediatric Cardiology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC.
Sarah N TaylorDivision of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC.
Andrew M AtzDivision of Pediatric Cardiology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC.
Carol L WagnerDivision of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC.
Medical University of South Carolina · US

Funding

South Carolina Clinical & Translational Research Institute (SCTR)UL1TR000062 · NCATS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2012 to 2014
$9.4M
NCATS NIH HHS UL1 TR000062NCATS NIH HHS UL1TR000062
6 · The paper itself

Abstract

objectivesTo evaluate intestinal barrier function in neonates undergoing cardiac surgery using lactulose/mannitol (L/M) ratio measurements, and to determine correlations with early breast milk feeding. STUDY

designThis was a single-center, prospective, randomized pilot study of 27 term-born neonates (≥ 37 weeks gestation) requiring cardiac surgery who were randomized to 1 of 2 preoperative feeding groups: nil per os (NPO) or trophic (10 mL/kg/day) breast milk feeds. At 3 time points (preoperative [preop], postoperative [postop] day 7, and postop day 14), subjects were administered an oral L/M solution, after which urine L/M ratios were measured using gas chromatography, with higher ratios indicative of increased intestinal permeability. Trends over time in the mean urine L/M ratios for each group were estimated using a general linear mixed model.

resultsThere were no adverse events related to preoperative trophic feeding. In the NPO group (n = 13), the mean urine L/M ratio was 0.06 at preop, 0.12 at postop day 7, and 0.17 at postop day 14. In the trophic breast milk feeds group (n = 14), the mean urine L/M ratio was 0.09 at preop, 0.19 at postop day 7, and 0.15 at postop day 14. In both groups, L/M ratios were significantly higher at postop day 7 and postop day 14 compared with preop (P < .05).

conclusionNeonates have increased intestinal permeability after cardiac surgery extending to at least postop day 14. This pilot study was not powered to detect differences in benefit or adverse events comparing the NPO and trophic breast milk feeds groups. Further studies to identify mechanisms of intestinal injury and therapeutic interventions are warranted.

trial registrationRegistered with ClinicalTrials.gov: NCT01475357.

Indexed as

Milk, HumanBiomarkersCardiac Surgical ProceduresEnteral NutritionEnterocolitis, NecrotizingFemaleHumansInfant FormulaInfant, NewbornIntestinal MucosaLactuloseMaleMannitolPermeabilityPilot ProjectsPreoperative CareBiomarkersLactuloseMannitol

Identifiers

PMID25962930
PMCPMC4485947
OpenAlexW1562471600

What OpenQuestion holds

Textmetadata
LicenceTDM
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.