Comparison of Phenobarbital versus Morphine in the management of neonatal abstinence syndrome
- Conditions
- eonatal Abstinence Syndrome.Drug withdrawal syndrome in infant of dependent mother
- Registration Number
- IRCT201406239568N8
- Lead Sponsor
- The Research Deputy of Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria:
1. neonates born at = 35 weeks of gestation
2. exposure to addictive drugs in utero (determined by maternal history and positive maternal opiate screen during the last trimester of pregnancy)
3. demonstration of signs and symptoms of NAS requiring treatment (3 consecutive Finnegan score of 8 or more or 2 consecutive Finnegan score of 12 or more as calculated every 4 hours by the physician)
1. neonates born at < 35 weeks of gestation
2. neonates who had intra uterine growth retardation (IUGR)
3. neonates with congenital anomalies
4. neonates with major concomitant medical illness requiring oxygen therapy, intravenous fluids or medications
5. neonates with neurologic abnormality
6. breastfed neonates
7. concomitant maternal Benzodiazepine or alcohol use
8. neonates whose parents refused to give informed consent.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The duration of pharmacologic treatment needed for the resolution of symptoms of NAS. Timepoint: Every 4 hours the Finnegan Score is measured by the physician till the score falls below 8. Method of measurement: Finnegan Score calculated by the physician every 4 hours.
- Secondary Outcome Measures
Name Time Method The total duration of hospital stay. Timepoint: Measured once at the end of hospital admission. Method of measurement: Measured based on the medical records of the neonate.;The requirement for adjunctive therapy. Timepoint: Measured daily till the end of neonatal admission. Method of measurement: Measured based on the theraputic and medical records of the neonate.