Dettagli per singolo studio

DEC-NET Serial number GB268

Published online	30/06/2004 14.04.00
Last updated	03/10/2005 10.04.35

Other protocol ID number	N0024128034
This trial has been approved by an ethics committee
Current trial status	Complete(closed to recruitment of participants: follow-up complete)
First subject enrolment Target N. of subjects	08/2003 704
Major Disease (ICD9 class)	HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE
Experimental drug
Antiretrovirals Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	0 - 9 years
Eligibility criteria
Inclusion criteria
Uninfected children born to HIV infected women in the UK, identified through routine national surveillance
Exclusion criteria
Parents refuse consent
Trial design/methodology
Phase	0
Kind of study	Safety
Design	Survey; Laboratory Study and Questionnaire
Purpose of study
To explore the association of exposure to antiretroviral therapy in fetal or early life with adverse neonatal outcomes or subsequent health problems in uninfected children born to HIV infected women.
Primary outcomes
Neonatal outcomes & morbidity in childhood, eg height, weight, hospital admissions, medical outcomes


Summary of study design, objectives, and ongoing research findings
The aim of the study was to explore the association of exposure to antiretroviral therapy in fetal or early life with adverse neonatal outcomes or subsequent health problems in uninfected children born to HIV infected women. The chart study is a consented annual follow-up. a questionnaire on the child's health and development is completed by a health professional in consultation with the parent/carer. Children were identified through routine national surveillance.