Clinical trial NCT02810782: How to Treat Opiate Withdrawal in Neonates
Official title: Pharmacological Treatment of Narcotic Neonatal Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neonatal Abstinence Syndrome
Keywords: opiate dependence
withdrawal
newborn
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of treatment
timeFrame: 0 to 42 days
Secondary outcomes:
measure: Incidence of convulsions
timeFrame: Whole time of hospitalisation (up to 10 weeks)
measure: Weight gain
timeFrame: through study completion, up to 10 weeks
measure: Treatment failures (need for adding second medication)
timeFrame: through study completion, up to 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Zurich
name: Hans U Bucher, Prof
role: STUDY_CHAIR
References:
citation: Zimmermann U, Rudin C, Duo A, Held L, Bucher HU; Swiss neonatal abstinence syndrome study group. Treatment of opioid withdrawal in neonates with morphine, phenobarbital, or chlorpromazine: a randomized double-blind trial. Eur J Pediatr. 2020 Jan;179(1):141-149. doi: 10.1007/s00431-019-03486-6. Epub 2019 Nov 6.