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Clinical Trials/IRCT201406239568N8
IRCT201406239568N8
Completed
未知

Comparison of Phenobarbital versus Morphine in the management of neonatal abstinence syndrome, a randomized controlled trial

The Research Deputy of Tehran University of Medical Sciences0 sites60 target enrollmentTBD
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Conditionseonatal Abstinence Syndrome.Drug withdrawal syndrome in infant of dependent mother

Overview

Phase
未知
Intervention
Not specified
Conditions
eonatal Abstinence Syndrome.
Sponsor
The Research Deputy of Tehran University of Medical Sciences
Enrollment
60
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
The Research Deputy of Tehran University of Medical Sciences

Eligibility 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.

Outcomes

Primary Outcomes

Not specified

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