Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/21/2019 |
| Start Date: | December 7, 2017 |
| End Date: | January 2022 |
| Contact: | Henrietta Bada, MD MPH |
| Email: | hbada2@uky.edu |
| Phone: | 859-323-5530 |
The long term goals of our research are to establish the best pharmacological treatment for
NAS and determine how pharmacologic treatment of NAS affects long-term developmental
outcomes. The objective of this application is to evaluate the effectiveness of clonidine as
a treatment for neonates with NAS, in a randomized clinical trial. Our central hypothesis is
that clonidine will effectively treat drug withdrawal manifestations in neonates.
NAS and determine how pharmacologic treatment of NAS affects long-term developmental
outcomes. The objective of this application is to evaluate the effectiveness of clonidine as
a treatment for neonates with NAS, in a randomized clinical trial. Our central hypothesis is
that clonidine will effectively treat drug withdrawal manifestations in neonates.
In this current proposal, the research plan is based on our pilot study, which randomized
infants with NAS to receive morphine or clonidine. The treatment groups were similar as to
mean birth weight, gestational age, Apgar scores, and postnatal age at treatment. Infants
enrolled had no other medical or surgical complications. Treatment was initiated per our NICU
standard at the time, and will be continued in this protocol. Total LOS was shorter by about
1 week in the clonidine (mean of 15 days), compared to 21 days in the morphine group.
Aims and Objectives:
To determine whether the treatment of NAS with a non-opiate medication, clonidine, will be
more effective than morphine
- Compare Clonidine and morphine for the treatment of NAS. Compare the efficacy of each
drug which is determined by duration of treatment in number of days, number of dose
escalations needed to achieve needed treatment, and the need for second drug treatment.
- Evaluate the neurobehavioral performance scores (habituation, orientation, self-
regulation, motor/reflexes, and stress/ abstinence scales) using the neonatal intensive
care (NICU) network neurobehavioral scale (NNNS) in both treatment groups. This exam
will take place after treatment begins, and at one month post-natal age (38-44 weeks
post menstrual age) or at discharge, whichever comes first.
To determine whether treatment of NAS with clonidine will result in better early childhood
outcomes than those treated with morphine • Compare the cognitive, motor and behavioral
development of children in both treatment groups using the Bayley III Scales of Infant
Development at 6 months, one and two years of age.
To build population pharmacokinetic/pharmacodynamic models and determine factors that affect
exposure and response to morphine and clonidine
• Measure blood levels obtained at random times and correlate to Finnegan scores. The
pharmacodynamics may help with understanding NAS medications and coping measures in babies.
infants with NAS to receive morphine or clonidine. The treatment groups were similar as to
mean birth weight, gestational age, Apgar scores, and postnatal age at treatment. Infants
enrolled had no other medical or surgical complications. Treatment was initiated per our NICU
standard at the time, and will be continued in this protocol. Total LOS was shorter by about
1 week in the clonidine (mean of 15 days), compared to 21 days in the morphine group.
Aims and Objectives:
To determine whether the treatment of NAS with a non-opiate medication, clonidine, will be
more effective than morphine
- Compare Clonidine and morphine for the treatment of NAS. Compare the efficacy of each
drug which is determined by duration of treatment in number of days, number of dose
escalations needed to achieve needed treatment, and the need for second drug treatment.
- Evaluate the neurobehavioral performance scores (habituation, orientation, self-
regulation, motor/reflexes, and stress/ abstinence scales) using the neonatal intensive
care (NICU) network neurobehavioral scale (NNNS) in both treatment groups. This exam
will take place after treatment begins, and at one month post-natal age (38-44 weeks
post menstrual age) or at discharge, whichever comes first.
To determine whether treatment of NAS with clonidine will result in better early childhood
outcomes than those treated with morphine • Compare the cognitive, motor and behavioral
development of children in both treatment groups using the Bayley III Scales of Infant
Development at 6 months, one and two years of age.
To build population pharmacokinetic/pharmacodynamic models and determine factors that affect
exposure and response to morphine and clonidine
• Measure blood levels obtained at random times and correlate to Finnegan scores. The
pharmacodynamics may help with understanding NAS medications and coping measures in babies.
Inclusion Criteria:
- Gestational age (GA) > or equal to 35 weeks
- Known prenatal opiate exposure (by mother admitting use, mom with positive opiate
screen during pregnancy, or positive neonatal urine and meconium screening)
- No known prenatal cocaine exposure
- No morphine or clonidine dose before enrollment
- Symptomatic with Finnegan scores (FS): 3 consecutive scores greater than or equal to
8, OR 2 consecutive scores greater than or equal to 12, and/or with attending decision
to treat for NAS
- Less than or equal to 7 days of age
- Attending physician decides to start pharmacologic treatment and agrees to infant's
study participation
Exclusion Criteria:
- Seizures
- Major congenital malformations
- Blood pressure instability
- Major medical condition in addition to NAS
- Parents unable to understand English
We found this trial at
1
site
740 South Limestone Street
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Principal Investigator: Henrietta Bada, MD/MPH
Phone: 859-323-6654
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