Jesper Kjærgaard1, Lone Graff Stensballe2, Nina Marie Birk3, Thomas Nørrelykke Nissen3, Lisbeth Marianne Thøstesen4, Gitte Thybo Pihl4, Agnethe Vale Nielsen2, Poul-Erik Kofoed4, Peter Aaby5, Ole Pryds3, Gorm Greisen6. 1. Research Unit Womens' and Childrens' Health, The Department of Paediatrics and Adolescent Medicine, Juliane Marie Centret, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark; The Neonatal Department, Juliane Marie Centret, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark. Electronic address: Jesper.kjaergaard@regionh.dk. 2. Research Unit Womens' and Childrens' Health, The Department of Paediatrics and Adolescent Medicine, Juliane Marie Centret, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark. 3. Department of Paediatrics, 460, Copenhagen University Hospital, Hvidovre, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark. 4. Department of Paediatrics, Kolding Hospital, Skovvangen 2-8, DK-6000 Kolding, Denmark; Institute of Regional Health Research, University of Southern Denmark, Denmark. 5. Bandim Health Project, Statens Serum Institut, Artillerivej 5, DK-2300 Copenhagen S, Denmark. 6. The Neonatal Department, Juliane Marie Centret, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark.
Abstract
BACKGROUND:Bacillus Calmette-Guérin vaccine (BCG) induces a complex, pro-inflammatory immune response. Obesity is associated with low-grade inflammation. AIMS: The purpose of the study was to test whether BCG at birth has effects on infant growth and body composition. STUDY DESIGN, SUBJECTS, AND OUTCOME MEASURES: The Danish Calmette Study is a randomized, clinical trial. The study was conducted at three university hospitals and randomized 4262 children of gestational age ≥32weeks to receive BCG within seven days of birth or to a no-intervention control group. Follow-up consisted of clinical examinations. Outcome measures were weight and length at 3months, and weight, length, mid upper-arm circumference, and triceps and subscapular skinfold at 13months. Data collectors were blinded to allocation. Anthropometric measurements were converted to z-scores using WHO reference population. RESULTS: Follow-up was 94% complete at 3 and 13months after birth. The children were bigger than the WHO reference population. There was no effect of BCG on weight z-score at 13months (-0.028 [95% confidence interval: -0.085 to 0.029], p=0.34). There was no effect on weight and length at 3months, or length, mid-upper-arm circumference, or triceps and subscapular skinfold at 13months. CONCLUSION: In this study, vaccination with BCG at birth did not have effects on child growth or body composition at 13months. TRIAL REGISTRATION: www.clinicaltrials.gov, registration number NCT01694108.
RCT Entities:
BACKGROUND: Bacillus Calmette-Guérin vaccine (BCG) induces a complex, pro-inflammatory immune response. Obesity is associated with low-grade inflammation. AIMS: The purpose of the study was to test whether BCG at birth has effects on infant growth and body composition. STUDY DESIGN, SUBJECTS, AND OUTCOME MEASURES: The Danish Calmette Study is a randomized, clinical trial. The study was conducted at three university hospitals and randomized 4262 children of gestational age ≥32weeks to receive BCG within seven days of birth or to a no-intervention control group. Follow-up consisted of clinical examinations. Outcome measures were weight and length at 3months, and weight, length, mid upper-arm circumference, and triceps and subscapular skinfold at 13months. Data collectors were blinded to allocation. Anthropometric measurements were converted to z-scores using WHO reference population. RESULTS: Follow-up was 94% complete at 3 and 13months after birth. The children were bigger than the WHO reference population. There was no effect of BCG on weight z-score at 13months (-0.028 [95% confidence interval: -0.085 to 0.029], p=0.34). There was no effect on weight and length at 3months, or length, mid-upper-arm circumference, or triceps and subscapular skinfold at 13months. CONCLUSION: In this study, vaccination with BCG at birth did not have effects on child growth or body composition at 13months. TRIAL REGISTRATION: www.clinicaltrials.gov, registration number NCT01694108.
Authors: Cristian Alfredo Segura-Cerda; Brenda Marquina-Castillo; Vasti Lozano-Ordaz; Dulce Mata-Espinosa; Jorge Alberto Barrios-Payán; Manuel O López-Torres; Michel de Jesús Aceves-Sánchez; Helle Bielefeldt-Ohmann; Rogelio Hernández-Pando; Mario Alberto Flores-Valdez Journal: NPJ Vaccines Date: 2020-03-12 Impact factor: 7.344
Authors: Cristian Alfredo Segura-Cerda; Brenda Marquina-Castillo; Vasti Lozano-Ordaz; Dulce Mata-Espinosa; Jorge Alberto Barrios-Payán; Manuel O López-Torres; Michel de Jesús Aceves-Sánchez; Helle Bielefeldt-Ohmann; Rogelio Hernández-Pando; Mario Alberto Flores-Valdez Journal: NPJ Vaccines Date: 2020-03-12 Impact factor: 7.344