Version 1.0 - Investigating neonatal opiate abstinence syndrome (NAS).
Research type
Research Study
Full title
An investigation into the relationship between the dose of methadone or buprenorphine (opiate substitution treatment; OST)prescribed during pregnancy, maternal methadone or buprenorphine plasma concentrations in the third trimester of pregnancy, neonatal methadone or buprenorphine plasma concentrations at birth, and the subsequent development of neonatal opiate abstinence syndrome (NAS).
IRAS ID
124847
Contact name
Kim Wolff
Contact email
Research summary
Heroin dependence in pregnancy is managed by prescribing pregnant women substitute long-acting synthetic opioids (opiate substitution therapy ’OST’) in combination with specialist counselling (Winklbaur et al, 2008). Babies born to women receiving OST in pregnancy could theoretically be born dependent on methadone or buprenorphine and subsequently experience opiate withdrawal following birth (NAS).
This study is important because the existing evidence is conflicting regarding the relationship between maternal OST dose in pregnancy and the development of opiate withdrawal in the neonate. The aim of this study is to investigate NAS in neonates to address this gap in our knowledge.
Pregnant woman who are receiving OST from the Calderdale Perinatal Substance Misuse Service (CPSMS)will be eligible to participate in the study. As part of the Perinatal Team, the Researcher will have access to these women. The CPSMS is a multi-disciplinary team comprising of health care professionals from both Calderdale Substance Misuse Service ( part of South West Yorkshire Partnership NHS Foundation Trust) and Calderdale and Huddersfield NHS Trust.
Women will be recruited from the service over a period of 5 years. Patient demographic and health data will be obtained by self-report. Study data will be obtained by collecting blood samples from the mother during the third trimester of pregnancy and at birth, and by collecting cord blood and urine samples from the neonate at birth and the immediate postnatal period. Neonates will be observed for signs of NAS for five days following birth.
Secondly, I will investigate the attitudes and understanding of healthcare providers regarding NAS in neonates.
Thirdly, I will investigate how NAS is diagnosed in different specialist units in England.
I will review patients’ case notes to ensure full details of substance misuse history are assessed.
Winklbaur et al (2008) Treating pregnant women dependent on opioids. Addiction 103: 1429-1440
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
13/LO/1370
Date of REC Opinion
8 Apr 2014
REC opinion
Further Information Favourable Opinion