Neonatal Abstinence Syndrome
Conditions
Keywords
opiate dependence, withdrawal, newborn
Brief summary
Three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. Major objective is to investigate the duration of drug treatment based on the Finnegan score. Secondary objectives are to document weight gain, the need for adding a second drug when the first drug is not effective enough and possible side effects such as convulsions.
Detailed description
Background: Neonatal narcotic abstinence syndrome is an important medical, social and financial problem. Several drugs are used to treat the withdrawal symptoms in neonates that have been exposed to opiates in utero, but there is no consensus which one is best. Goal: Three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. Major objective is to investigate the duration of drug treatment based on the Finnegan score. Secondary objectives are to document weight gain, the need for adding a second drug when the first drug is not effective enough and possible side effects such as convulsions. Methods: Neonates born after 34 completed weeks of gestation with meconium proven antenatal opiate exposure and parental informed consent are included. Infants with severe malformation are excluded. Each infant is assessed every eight hour by a modified Finnegan score. When 9 points are exceeded drug treatment is started and dose increased stepwise according to the score. The masqued solution applied orally contains morphine, phenobarbital or chlorpromazine. When the maximum dose does not reduce the score, a second randomisation and one of the two remaining drugs is added, again in a blinded way. A total of 120 infants, 40 in each group will be included in the study.
Interventions
DRUGPhenobarbital
Phenobarbital per os
DRUGChlorpromazine
Chlorpromazine per os
DRUGMorphine
Morphine per os
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Hours to 3 Days
Healthy volunteers
No
Inclusion criteria
* Neonates of mothers who consumed opiates during pregnancy * Born after 34 completed weeks of pregnancy * Parents' informed consent
Exclusion criteria
* Preterm birth before 34 0/7 gestational weeks * Severe malformation * Illness requiring respiratory assistance or catecholamines * Negative meconium drug test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of treatment | 0 to 42 days | Treatment is reduced stepwise until withdrawal symptoms have gone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failures (need for adding second medication) | through study completion, up to 10 weeks | Need for additional drug if investigational drug does not control withdrawal symptoms |
| Incidence of convulsions | Whole time of hospitalisation (up to 10 weeks) | — |
| Weight gain | through study completion, up to 10 weeks | — |
Outcome results
None listed