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Trial record 71 of 325 for:    clonidine

Clonidine for Neonatal Abstinence Syndrome Study

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ClinicalTrials.gov Identifier: NCT01175668
Recruitment Status : Terminated (Based on the planned interim analysis results at 50% recruitment, after IRB reviewed the results, further enrollment was stopped.)
First Posted : August 5, 2010
Results First Posted : January 6, 2014
Last Update Posted : January 6, 2014
Sponsor:
Information provided by (Responsible Party):
Rachana Singh, MD, Baystate Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neonatal Abstinence Syndrome
Interventions Drug: Clonidine
Drug: Phenobarbital
Enrollment 68
Recruitment Details The study was conducted at Baystate Children’s Hospital Davis Neonatal Intensive Care Unit (NICU), a level III, regional perinatal referral center, for Western Massachusetts, from June 2010 to June 2012
Pre-assignment Details Overall 82 infants were consented for the study but 14 were excluded either because they did not have continued high modified Finnegan Scores (n=13), or had Unstable clinical status (n=1)
Arm/Group Title NMS/Clonidine NMS/Phenobarbital
Hide Arm/Group Description

Dosing was based on the Finnegan scores as below

Finn Score 8-10 NMS 0.32mg/kg/day + Clonidine 6 mcg/kg/day 11-13 NMS 0.48 mg/kg/day + Clonidine 8 mcg/kg/day 14-16 NMS 0.64 mg/kg/day + Clonidine 10 mcg/kg/day ≥17 NMS 0.8 mg/kg/day* + Clonidine 12 mcg/kg/day

Daily NMS dose was divided for q3h dosing interval Daily Clonidine dose was divided for q6h dosing interval Clonidine escalation may be limited by hypotension or bradycardia

*If needing morphine sulfate > 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score < 8

Dosing was based on the Finnegan scores as below

Finn Score 8-10 NMS 0.32mg/kg/day +Phenobarbital 6 mg/kg/day 11-13 NMS 0.48 mg/kg/day +Phenobarbital 8 mg/kg/day 14-16 NMS 0.64 mg/kg/day +Phenobarbital 10 mg/kg/day ≥17 NMS 0.8 mg/kg/day* + Phenobarbital 12 mg/kg/day

Daily NMS dose was divided for q3h dosing interval Daily Phenobarbital dose was divided for q8h dosing interval

*If needing morphine sulfate > 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score < 8

Period Title: Overall Study
Started 34 34
Completed 32 34
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             2             0
Arm/Group Title NMS/Clonidine NMS/Phenobarbital Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 34 34 68
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 34 participants 34 participants 68 participants
1.8  (0.9) 2.26  (1.60) 2.05  (1.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 68 participants
Female
19
  55.9%
16
  47.1%
35
  51.5%
Male
15
  44.1%
18
  52.9%
33
  48.5%
1.Primary Outcome
Title Length of Treatment With Neonatal Morphine Sulfate
Hide Description [Not Specified]
Time Frame subjects were followed for the duration of treatment, up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NMS/Clonidine NMS/Phenobarbital
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 32 34
Mean (95% Confidence Interval)
Unit of Measure: days
18.2
(14.9 to 21.5)
13.6
(11.0 to 16.1)
2.Secondary Outcome
Title Total Dose of NMS Used
Hide Description [Not Specified]
Time Frame For the duration of treatment, upto 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NMS/Clonidine NMS/Phenobarbital
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 32 34
Mean (95% Confidence Interval)
Unit of Measure: mg/kg
5.7
(4.7 to 6.8)
4.6
(3.8 to 5.4)
Time Frame During the hospital stay
Adverse Event Reporting Description In the phenobarbital group, 3 infants (8.8%), manifested over sedation signs (poor feeds, and mild respiratory depression). This prompted serum phenobarbital measurements which were noted to be supra-therapeutic (>40 mg/dL) and required dosage adjustment.
 
Arm/Group Title NMS/Clonidine NMS/Phenobarbital
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
NMS/Clonidine NMS/Phenobarbital
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NMS/Clonidine NMS/Phenobarbital
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      0/34 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NMS/Clonidine NMS/Phenobarbital
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      3/34 (8.82%)    
Nervous system disorders     
Oversedation  0/34 (0.00%)  0 3/34 (8.82%)  3
One of the major limitations to our study was the inability to blind the two groups for the study medications.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rachana Singh, MD
Organization: Baystate Medical Center
Phone: 413-794-2400
EMail: rachana.singhmd@bhs.org
Layout table for additonal information
Responsible Party: Rachana Singh, MD, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT01175668     History of Changes
Other Study ID Numbers: BH-10-196
First Submitted: July 14, 2010
First Posted: August 5, 2010
Results First Submitted: September 3, 2013
Results First Posted: January 6, 2014
Last Update Posted: January 6, 2014