Evidence map›Paper›PMID 30115086›Full record

Trial reportItalian journal of pediatrics2018

Tolerance of preterm formula versus pasteurized donor human milk in very preterm infants: a randomized non-inferiority trial.

Simonetta Costa, Luca Maggio, Giovanni Alighieri, Giovanni Barone, Francesco Cota, Giovanni Vento

Open access · goldAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Italian journal of pediatrics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 4 pooled it
1.1field-weighted citation impact, top 24% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 4 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. [Clinical guidelines for the diagnosis and treatment of feeding intolerance in preterm infants (2020)].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2020
    Article
  11. 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.

Simonetta CostaDepartment of Woman and Child Health, Obstetric and Neonatology Area, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy. simonetta.costa@policlinicogemelli.it.ORCID http://orcid.org/0000-0003-0980-5297
Luca MaggioDepartment of Woman and Child Health, Obstetric and Neonatology Area, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.
Giovanni AlighieriDepartment of Woman and Child Health, Obstetric and Neonatology Area, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.
Giovanni BaroneDepartment of Woman and Child Health, Obstetric and Neonatology Area, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.
Francesco CotaDepartment of Woman and Child Health, Obstetric and Neonatology Area, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.
Giovanni VentoDepartment of Woman and Child Health, Obstetric and Neonatology Area, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.
Agostino Gemelli University Polyclinic · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHuman milk (HM) is the best feeding for premature infants. When own mother's milk (OMM) is insufficient or unavailable, pasteurized donor human milk (PDHM) and preterm formula (PF) are the alternative nutritional sources, but the benefits of donor milk over formula are not defined. This study aimed to assess whether, in the absence of OMM, the PF could guarantee a feeding tolerance not inferior to that seen with the use of PDHM during the first two weeks of life of very preterm infants.

methodsInfants with gestational age (GA) of ≤32 weeks who started enteral feeding within the first 7 days of life were randomized to receive PDHM or PF as a supplement to the OMM insufficient or unavailable. The primary outcome was the day of life when full enteral feeding (FEF) of 150 mL/Kg/d was achieved.

resultsSeventy infants were randomized, 35 in the PF group (GA 30.2 ± 1.7 weeks; BW 1342 ± 275 g), 35 in the PDHM group (GA 30 ± 1.9 weeks; BW 1365 ± 332 g). The time to achieve FEF was the same for infants fed with PF and for infants fed with PDHM (12.3 ± 7.0 days vs 12.8 ± 6.5).

conclusionsThis trial shows that PF could be a valid alternative for the early feeding of very preterm infants when OMM is insufficient or unavailable.

trial registrationUMIN000013922 . Date of formal registration: December 31, 2014.

Indexed as

Infant, Extremely PrematureInfant FormulaChild DevelopmentFemaleFollow-Up StudiesGestational AgeHumansInfant, NewbornInfant Nutritional Physiological PhenomenaInfant, PrematureMaleMilk, HumanPasteurizationPatient SelectionRisk AssessmentWeight GainFeeding tolerancePasteurized donor human milkPreterm formulaVery preterm infant

Identifiers

PMID30115086
PMCPMC6097280
OpenAlexW2886050012

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.