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

ABSTRACT: Randomised 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.Two-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.Overall 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.Though 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.ClinicalTrials.gov (NCT00146302).

SUBMITTER: Biering-Sorensen S

PROVIDER: S-EPMC4587923 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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

Biering-Sørensen Sofie S Andersen Andreas A Ravn Henrik H Monterio Ivan I Aaby Peter P Benn Christine Stabell CS

BMC pediatrics 20150928

<h4>Background</h4>Randomised 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.<h4>Methods</h4>Two-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 = 17 ...[more]

PMID: 26416147

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Project description:BackgroundMalnutrition and low birth weight (LBW) are two common causes of morbidity and mortality among children in sub-Saharan Africa. Both malnutrition and LBW affect early childhood development with long term consequences that may vary in their degree depending on the geographical setting. This study evaluates growth, nutritional status and mortality of infants from Lambaréné and Fougamou in Gabon from a birth cohort of a malaria in pregnancy clinical trial (NCT00811421).MethodA prospective longitudinal birth cohort conducted between 2009 and 2012, included infants that were followed up from birth until their first-year anniversary. The exposure of interest was low birth weight and the outcomes explored were growth represented by weight gain, the nutritional status including stunting, wasting and underweight, and the mortality. Scheduled follow-up visits were at one, nine and 12 months of age. Logistic regression was used to assess the association between low birth weight and growth and nutritional outcomes, and cox regression was used for mortality.ResultA total of 907 live-born infants were included in the analysis. The prevalence of LBW was 13% (115). At one month of life, out of 743 infants 10% and 4% presented with stunting and underweight, respectively, while these proportions increased at 12 months of life to 17% and 21%, respectively, out of 530 infants. The proportion of infants with wasting remained constant at 7% throughout the follow-up period. Stunting and underweight were associated with LBW, adjusted odds ratio (aOR): 2.6, 95% confidence interval (95%CI): 1.4-4.9 and aOR: 4.5, 95%CI: 2.5-8.1, respectively. Preterm birth was associated with stunting, aOR: 2.7, 95%CI: 1.2-6.3 and underweight, aOR: 5.4, 95%CI: 1.7-16.1 at one month of life. Infants with LBW were at higher hazard of death during the first year of life, adjusted hazard ratio 4.6, 95%CI: 1.2-17.0.ConclusionLow birthweight infants in Gabon are at higher risks of growth and nutritional deficits and mortality during the first year of life. Tailored interventions aiming at preventing adverse pregnancy outcomes including LBW, early detection and appropriate management of growth, and nutritional deficits in infants are necessary in Gabon.

Project description:BackgroundLow birth weight (LBW) is one of the leading causes of adverse perinatal outcomes and is closely related to neonatal disease and death. The incidence of LBW has been increasing. The aim of this study was to investigate the current incidence rate and factors affecting low birth weight infants and perinatal outcomes of full-term low birth weight infants in mainland China.MethodsThis paper describes a retrospective analysis of children born in 39 hospitals of different types in 14 different provinces, municipalities, and autonomous regions in seven districts within China throughout 2011. The data were first collected in hardcopy format and then entered into computer network databases. Data covering a total of 112,441 cases were collected. Cases were excluded if data were incomplete and in the case of miscarriage before 24 weeks of gestation, multiple pregnancies, or induction of labor due to fetal malformation, intrauterine death, and other reasons, leaving a total of 101,163 cases. SPSS 18.0 and SAS 9.2 statistical packages were used to analyze the collected data.ResultsAccording to this research, the incidence of LBW in mainland China was 6.1%, which is higher than the 5.87% reported in 2000, and it varied across different areas. The incidence of LBW was significantly higher in tertiary care hospitals than in secondary care hospitals. LBW was found to be associated with maternal age of less than 20 years, low level of maternal education, previous histories of adverse pregnancies, and with pregnancy comorbidities and complications, such as hypertensive disorders during pregnancy, anemia, oligohydramnios, premature rupture of membranes, and gestational diabetes. The rates of stillbirths, severe neonatal asphyxia, and deaths among full-term LBW infants were 2.42%, 0.83%, and 3.49%, respectively. The rates of stillbirths and neonatal deaths among full-term LBW infants born by caesarean section were 0.5% and 1.0%, respectively, which was lower than vaginal delivery.ConclusionsThe incidence of LBW has increased in China. LBW is a leading cause of adverse pregnancy outcomes. Health care during pregnancy and management of high-risk factors for LBW may reduce the incidence of LWB and the death rate of LBW infants.

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

Publications

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

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