Evidence map›Paper›PMID 36514058›Full record

Observational studyBMC pediatrics2022

Infant feeding practice and gastrointestinal tolerance: a real-world, multi-country, cross-sectional observational study.

Happy Tummy Consortium, Luca Lavalle, Nicolas Sauvageot, Colin Ivano Cercamondi, Delphine Egli, Ivana Jankovic, Yvan Vandenplas

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in BMC pediatrics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03703583 (Infant Feeding Practice and Gut Comfort), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.4field-weighted citation impact, top 17% 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.

NCT03703583 completednot on this map

Infant Feeding Practice and Gut Comfort: a Multi-country, Cross-sectional Observational Study

Typeobservational_patient_registrySponsorSociété des Produits Nestlé (SPN)Ran2018 to 2019Enrolled2,804ConditionsHealthy InfantsArmsThere is no intervention in this observational study.
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Nutrients · 2023
    Observational
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

7 authors at 2 institutions in 2 countries.

Happy Tummy Consortium
Luca LavalleBiostatistics & Data, Nestlé Research, Lausanne, Switzerland.
Nicolas SauvageotBiostatistics & Data, Nestlé Research, Lausanne, Switzerland.
Colin Ivano CercamondiNestlé Product Technology Center - Nutrition, Société Des Produits Nestlé S.A., 1800, Vevey, Switzerland.
Delphine EgliNestlé Product Technology Center - Nutrition, Société Des Produits Nestlé S.A., 1800, Vevey, Switzerland. Delphine.Egli@nestle.com.
Ivana JankovicNestlé Product Technology Center - Nutrition, Société Des Produits Nestlé S.A., 1800, Vevey, Switzerland.
Yvan VandenplasVrije Universiteit Brussel, UZ Brussels, KidZ Health Castle, Brussels, Belgium.
Nestlé (Switzerland) · CHVrije Universiteit Brussel · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSigns of feeding intolerance, such as gastrointestinal (GI) symptoms, are frequently observed in otherwise healthy formula-fed infants in the first months of life. The primary objective of this observational study was to examine GI tolerance in formula-fed infants (FFI) vs. breastfed infants (BFI) in a real-world setting with a secondary objective being the comparison of infants fed formula with pre- and/or probiotics (FFI_PP) and those fed formula without any pre- and/or probiotics (FFI_noPP) as well as BFI.

methodsA six-country, cross-sectional study in full-term exclusively/predominantly FFI (n = 2036) and BFI (n = 760) aged 6-16 weeks was conducted using the validated Infant Gastrointestinal Symptom Questionnaire (IGSQ) and a Feeding Practice and Gut Comfort Questionnaire.

resultsThe IGSQ composite score in FFI was non-inferior compared to BFI (mean difference [95%CI]: 0.17 [-0.34, 0.67]; non-inferiority p-value < 0.0001) and scores for BFI and FFI were below the threshold of 23, indicating no GI discomfort. Adjusted mean IGSQ scores ± SE were similar in FFI_PP (22.1 ± 0.2) and BFI (22.3 ± 0.3) while FFI_noPP (23.4 ± 0.3) was significantly higher and above 23 indicating some GI discomfort (mean differences [95%CI] FFI_noPP minus FFI_PP and FFI_noPP minus BFI were 1.28 [0.57, 1.98] and 1.09 [0.38, 1.80], respectively; both p < 0.01). Hard stools and difficulty in passing stool were more common in FFI compared to BFI (p < 0.01) but were less common in FFI_PP compared to FFI_noPP (p < 0.01). FFI_PP showed significantly less crying than FFI_noPP and was similar to BFI. Significantly fewer physician-confirmed colic episodes (Rome IV criteria) were reported in FFI_PP compared with FFI_noPP or BFI.

conclusionsIn this real-world observational study, FFI had non-inferior overall GI tolerance compared to BFI. Within FFI, infants receiving formulas with pre- and/or probiotics had a better GI tolerance, improved stooling and less infantile colic compared to those receiving formula without any pre- and/or probiotics and were more similar to BFI.

trial registrationNCT03703583, 12/10/2018 ( https://clinicaltrials.gov/ct2/show/NCT03703583 ).

Indexed as

ColicGastrointestinal DiseasesBreast FeedingCross-Sectional StudiesDouble-Blind MethodFemaleHumansInfantInfant FormulaInfant, NewbornCrying timeGastrointestinal toleranceInfant formulaInfantile colicPrebioticsProbioticsStooling pattern

Identifiers

PMID36514058
PMCPMC9749164
OpenAlexW4311305224

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.