PMID- 29625591 OWN - NLM STAT- MEDLINE DCOM- 20180917 LR - 20181114 IS - 1756-0500 (Electronic) IS - 1756-0500 (Linking) VI - 11 IP - 1 DP - 2018 Apr 6 TI - Neurodevelopmental assessment of HIV-exposed uninfected and early-treated HIV-infected children: study protocol. PG - 235 LID - 10.1186/s13104-018-3331-8 [doi] LID - 235 AB - OBJECTIVE: Sub-Saharan Africa has the highest prevalence of children at risk of not achieving their developmental potential, attributable largely to the human immunodeficiency virus (HIV) pandemic coupled with negative environmental factors. Childhood developmental stimulation programmes can mitigate adverse outcomes. METHODS: Neonates testing HIV positive at birth will be initiated on antiretroviral treatment (ART) and receive an age-appropriate stimulation program, updated at 3 monthly intervals through the first year of life. Neurodevelopment at 12 months of age will be assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III). Outcomes will be compared with HIV-infected and HIV-exposed uninfected children (HEU) not having received the stimulatory intervention. Associations between neurodevelopmental outcomes, environmental factors, and parental stress will be investigated. The study will take place at a single site in Johannesburg, South Africa. This non-randomised controlled intervention study, with a single non-blinded comparative intervention group, aims to investigate whether an early childhood stimulation programme used in conjunction with ART initiated at birth can positively impact neurodevelopmental outcomes at 1 year of age in children infected with HIV. Trial registration 15 January 2018, Pan African Clinical Trial Registry PACTR201801002967587. FAU - Strehlau, Renate AU - Strehlau R AUID- ORCID: 0000-0001-9113-6584 AD - Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. renate.strehlau@wits.ac.za. FAU - van Aswegen, Tamryn AU - van Aswegen T AD - Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. FAU - Potterton, Joanne AU - Potterton J AD - Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. AD - Department of Physiotherapy, School of Therapeutic Sciences, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. LA - eng PT - Controlled Clinical Trial PT - Journal Article DEP - 20180406 PL - England TA - BMC Res Notes JT - BMC research notes JID - 101462768 RN - 0 (Anti-HIV Agents) SB - IM MH - Anti-HIV Agents/administration & dosage/*pharmacology MH - Child Development/*physiology MH - Clinical Protocols MH - Early Medical Intervention/*methods MH - Female MH - Follow-Up Studies MH - HIV Infections/*drug therapy MH - HIV Seropositivity/drug therapy MH - Humans MH - Infant MH - Infant, Newborn MH - Male MH - Pregnancy MH - *Pregnancy Complications, Infectious MH - Prenatal Exposure Delayed Effects/*diagnosis/prevention & control MH - South Africa PMC - PMC5889550 OTO - NOTNLM OT - Early antiretroviral treatment OT - Early childhood development OT - HIV EDAT- 2018/04/08 06:00 MHDA- 2018/09/18 06:00 PMCR- 2018/04/06 CRDT- 2018/04/08 06:00 PHST- 2018/01/09 00:00 [received] PHST- 2018/03/26 00:00 [accepted] PHST- 2018/04/08 06:00 [entrez] PHST- 2018/04/08 06:00 [pubmed] PHST- 2018/09/18 06:00 [medline] PHST- 2018/04/06 00:00 [pmc-release] AID - 10.1186/s13104-018-3331-8 [pii] AID - 3331 [pii] AID - 10.1186/s13104-018-3331-8 [doi] PST - epublish SO - BMC Res Notes. 2018 Apr 6;11(1):235. doi: 10.1186/s13104-018-3331-8.