Sex-Differential Health Interventions In Low-Birth-Weight Infants

NCT00625482 | Completed

• 1 other identifier: 2007-7041-121
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Our group has consistently found that the major interventions to reduce morbidity and mortality in low-income countries have sex-differential effects. These interventions include BCG vaccine, oral polio vaccination (OPV), and vitamin A supplementation (VAS). Low-birth-weight (LBW) children constitute the largest high-risk group in low-income countries. According to current policy, they receive OPV at birth. Current evidence suggests that a policy of providing BCG with OPV for girls and VAS instead of OPV for boys at birth may improve survival in LBW neonates. This will be tested in a large randomized trial. We experienced an unexpected cluster of deaths among boys in the VAS arm, which could be due to chance, but we decided to stop randomizing boys to OPV or VAS. Very recent evidence has suggested that low-birth-weight boys may benefit from BCG at birth as well. Hence, we have obtained ethical permission to continue the trial with randomization of boys to OPV or OPV plus BCG.

Conditions

Mortality; Morbidity; Growth; Neonatal Mortality

Keywords

BCG vaccine; Oral polio vaccine; Vitamin A supplementation; Low-birth-weigth; Sex-differential; Prevention; Immunological parameters

Outcome Measures

Primary Outcomes (1)

• Mortality

Secondary Outcomes (5)

• Overall severe morbidity as measured by number of hospitalizations

• Morbidity due to rotavirus and malaria

• Growth

• BCG scar formation and PPD delayed type hypersensitivity (DTH) response

• Changes in cytokine profile

Study Arms (4)

Boys 1

ACTIVE COMPARATOR

OPV as usual

Biological: OPV

Boys 2

EXPERIMENTAL

OPV plus BCG

Biological: OPV plus BCG

Girls 1

ACTIVE COMPARATOR

OPV as usual

Biological: OPV

Girls 2

EXPERIMENTAL

OPV plus BCG

Biological: OPV plus BCG

Interventions

OPV BIOLOGICAL

Boys 1

OPV plus BCG BIOLOGICAL

Boys 2

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• Low-birth-weight infants (\<2500 g)

You may not qualify if:

• Already received BCG/OPV
• Overtly sick or have malformations at the time of enrolment
• Clinical signs of vitamin A deficiency (very unlikely)

Sponsors & Collaborators

• Bandim Health Project: lead
• March of Dimes: collaborator
• Danida: collaborator

Study Sites (1)

Bandim Health Project

Bissau, Guinea-Bissau

Location

Related Publications (8)

• Schaltz-Buchholzer F, Berendsen M, Roth A, Jensen KJ, Bjerregaard-Andersen M, Kjaer Sorensen M, Monteiro I, Aaby P, Stabell Benn C. BCG skin reactions by 2 months of age are associated with better survival in infancy: a prospective observational study from Guinea-Bissau. BMJ Glob Health. 2020 Sep;5(9):e002993. doi: 10.1136/bmjgh-2020-002993.

  PMID: 32978212 DERIVED

• Jensen KJ, Biering-Sorensen S, Ursing J, Kofoed PL, Aaby P, Benn CS. Seasonal variation in the non-specific effects of BCG vaccination on neonatal mortality: three randomised controlled trials in Guinea-Bissau. BMJ Glob Health. 2020 Mar 5;5(3):e001873. doi: 10.1136/bmjgh-2019-001873. eCollection 2020.

  PMID: 32201619 DERIVED

• Schaltz-Buchholzer F, Biering-Sorensen S, Lund N, Monteiro I, Umbasse P, Fisker AB, Andersen A, Rodrigues A, Aaby P, Benn CS. Early BCG Vaccination, Hospitalizations, and Hospital Deaths: Analysis of a Secondary Outcome in 3 Randomized Trials from Guinea-Bissau. J Infect Dis. 2019 Jan 29;219(4):624-632. doi: 10.1093/infdis/jiy544.

  PMID: 30239767 DERIVED

• Biering-Sorensen S, Aaby P, Lund N, Monteiro I, Jensen KJ, Eriksen HB, Schaltz-Buchholzer F, Jorgensen ASP, Rodrigues A, Fisker AB, Benn CS. Early BCG-Denmark and Neonatal Mortality Among Infants Weighing <2500 g: A Randomized Controlled Trial. Clin Infect Dis. 2017 Oct 1;65(7):1183-1190. doi: 10.1093/cid/cix525.

  PMID: 29579158 DERIVED

• Biering-Sorensen S, Jensen KJ, Monterio I, Ravn H, Aaby P, Benn CS. Rapid Protective Effects of Early BCG on Neonatal Mortality Among Low Birth Weight Boys: Observations From Randomized Trials. J Infect Dis. 2018 Feb 14;217(5):759-766. doi: 10.1093/infdis/jix612.

  PMID: 29216358 DERIVED

• Biering-Sorensen S, Jensen KJ, Aamand SH, Blok B, Andersen A, Monteiro I, Netea MG, Aaby P, Benn CS, Haslov KR. Variation of growth in the production of the BCG vaccine and the association with the immune response. An observational study within a randomised trial. Vaccine. 2015 Apr 21;33(17):2056-65. doi: 10.1016/j.vaccine.2015.02.056. Epub 2015 Mar 10.

  PMID: 25765965 DERIVED

• Lund N, Biering-Sorensen S, Andersen A, Monteiro I, Camala L, Jorgensen MJ, Aaby P, Benn CS. Neonatal vitamin A supplementation associated with a cluster of deaths and poor early growth in a randomised trial among low-birth-weight boys of vitamin A versus oral polio vaccine at birth. BMC Pediatr. 2014 Aug 28;14:214. doi: 10.1186/1471-2431-14-214.

  PMID: 25163399 DERIVED

• Eriksen HB, Biering-Sorensen S, Lund N, Correia C, Rodrigues A, Andersen A, Ravn H, Aaby P, Jeppesen DL, Benn CS. Factors associated with thymic size at birth among low and normal birth-weight infants. J Pediatr. 2014 Oct;165(4):713-21. doi: 10.1016/j.jpeds.2014.06.051. Epub 2014 Jul 30.

  PMID: 25085521 DERIVED

MeSH Terms

Interventions

Poliovirus Vaccine, Oral

Intervention Hierarchy (Ancestors)

Poliovirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2008
• First Posted: February 28, 2008
• Study Start: February 1, 2008
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

GU (1)