Evidence map›Paper›PMID 26416147›Full record

Trial reportBMC pediatrics2015

Early BCG vaccine to low-birth-weight infants and the effects on growth in the first year of life: a randomised controlled trial.

Sofie Biering-Sørensen, Andreas Andersen, Henrik Ravn, Ivan Monterio, Peter Aaby, Christine Stabell Benn

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC 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 NCT00146302 (BCG Vaccination and Childhood Morbidity and Mortality), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 41% 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.

NCT00146302 phase4completednot on this map

BCG Vaccination and Childhood Morbidity and Mortality: Interventions With Possible Implications for the Immunisation Policy in Developing Countries. Should Low Birth Weight Infants Be Vaccinated With BCG Vaccine at Birth?

TypeinterventionalSponsorBandim Health ProjectRan2002 to 2008Enrolled2,320ConditionsTuberculosisArmsBacille Calmette Guerin (BCG)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. 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

6 authors at 3 institutions in 2 countries.

Sofie Biering-SørensenResearch Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. s.biering@bandim.org.
Andreas AndersenResearch Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. a.andersen@bandim.org.
Henrik RavnResearch Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. hjn@ssi.dk.
Ivan MonterioProjécto de Saúde Bandim, INDEPTH Network, Codex 1004, Bissau, Guinea-Bissau. ivan130978@gmail.com.
Peter AabyProjécto de Saúde Bandim, INDEPTH Network, Codex 1004, Bissau, Guinea-Bissau. p.aaby@bandim.org.
Christine Stabell BennResearch Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. cb@ssi.dk.
Bandim Health Project · GWStatens Serum Institut · DKUniversity of Southern Denmark · DK

Funding

European Research Council 243149
6 · The paper itself

Abstract

backgroundRandomised trials have shown that early Bacille Calmette-Guérin (BCG) vaccine reduces overall neonatal and infant mortality. However, no study has examined how BCG affects growth. We investigated the effect on infant growth of early BCG vaccine given to low-birth-weight (LBW) infants.

methodsTwo-thousand three hundred forty-three LBW infants were randomly allocated 1:1 to "early BCG" (intervention group) or "late BCG" (current practice). Furthermore, a subgroup (N = 1717) were included in a two-by-two randomised trial in which they were additionally randomised 1:1 to vitamin A supplementation (VAS) or placebo. Anthropometric measurements were obtained 2, 6, and 12 months after enrolment.

resultsOverall there was no effect of early BCG on growth in the first year of life. The effect of early BCG on weight and mid-upper-arm circumference at 2 months tended to be beneficial among girls but not among boys (interaction between "early BCG" and sex: weight p = 0.03 and MUAC p = 0.04). This beneficial effect among girls was particularly seen among the largest infants weighing 2.0 kg or more at inclusion.

conclusionThough BCG vaccination is not recommended to be given to LBW infants at birth in Guinea-Bissau, early BCG had no negative effect on infant growth and may have had a beneficial effect for girls. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT00146302).

Indexed as

Adjuvants, ImmunologicAnthropometryBCG VaccineBody WeightDietary SupplementsFemaleHumansInfantInfant, Low Birth WeightInfant, NewbornMaleSex FactorsVitamin AVitaminsAdjuvants, ImmunologicBCG VaccineVitamin AVitamins

Identifiers

PMID26416147
PMCPMC4587923
OpenAlexW2115347919

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.