Neonatal Abstinence Syndrome. Drug withdrawal syndrome in infant of dependent mother
Conditions
Interventions
Intervention 1: Control Group:
In the randomly assigned oral morphine treatment group, initially 1 ml of a 10 mg Morphine Sulfate vial was diluted using 24 ml of distilled water, to make final concent
Treatment - Drugs
Control Group:
In the randomly assigned oral morphine treatment group, initially 1 ml of a 10 mg Morphine Sulfate vial was diluted using 24 ml of distilled water, to make final concentration of 0.4 m
Intervention Group:
In the randomly assigned Phenobarbital treatment group, initially a loading dose of 20 mg/kg IV or IM is administered then if the symptoms persists another 5mg/kg is given every 8
Sponsors
The Research Deputy of Tehran University of Medical Sciences
Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
No minimum to 5 Days
Inclusion criteria
Inclusion criteria: 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) Exclusion Criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Mahdi Sheikh
Maternal, Fetal and Neonatal Research Center, Tehran University of Medical SCIENCES
Outcome results
None listed