Trial Outcomes & Findings for Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome (NCT NCT01452789)
NCT ID: NCT01452789
Last Updated: 2020-03-24
Results Overview
This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
63 participants
Primary outcome timeframe
Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.
Results posted on
2020-03-24
Participant Flow
From November 1, 2011, to May 29, 2016, we enrolled term infants (≥37 weeks of gestation) who had been exposed to opioids in utero and had signs and symptoms of the neonatal abstinence syndrome.
Participant milestones
| Measure |
Sublingual Buprenorphine
sublingual buprenorphine: Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
|
Oral Morphine
oral morphine: Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
30
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Sublingual Buprenorphine
sublingual buprenorphine: Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
|
Oral Morphine
oral morphine: Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome
Baseline characteristics by cohort
| Measure |
Sublingual Buprenorphine
n=33 Participants
sublingual buprenorphine: Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
|
Oral Morphine
n=30 Participants
oral morphine: Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.5 gestational age months
n=5 Participants
|
39 gestational age months
n=7 Participants
|
38.7 gestational age months
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
30 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.Population: Intention to treat
This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution.
Outcome measures
| Measure |
Sublingual Buprenorphine
n=33 Participants
sublingual buprenorphine: Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
|
Oral Morphine
n=30 Participants
oral morphine: Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
|
|---|---|---|
|
Length of Treatment
|
15 days
Interval 3.0 to 67.0
|
28 days
Interval 13.0 to 67.0
|
SECONDARY outcome
Timeframe: Duration of hospital stay is an expected average of 5 weeks.Population: Intention to treat
This endpoint will compare length of stay in the hospital (in days) using sublingual buprenorphine or morphine solution.
Outcome measures
| Measure |
Sublingual Buprenorphine
n=33 Participants
sublingual buprenorphine: Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
|
Oral Morphine
n=30 Participants
oral morphine: Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
|
|---|---|---|
|
Length of Hospitalization
|
21 days
Interval 7.0 to 71.0
|
33 days
Interval 18.0 to 70.0
|
SECONDARY outcome
Timeframe: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.Population: Intention to treat
This endpoint will compare requirement number of patients who require use of supplemental phenobarbital.
Outcome measures
| Measure |
Sublingual Buprenorphine
n=33 Participants
sublingual buprenorphine: Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
|
Oral Morphine
n=30 Participants
oral morphine: Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
|
|---|---|---|
|
Number of Patients Requiring Supplemental Phenobarbital Treatment.
|
5 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.Population: Intention to treat
Adverse events will be collected, graded by severity, and assessed for causality referent to study drug.
Outcome measures
| Measure |
Sublingual Buprenorphine
n=33 Participants
sublingual buprenorphine: Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
|
Oral Morphine
n=30 Participants
oral morphine: Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
|
|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
7 Participants
|
8 Participants
|
Adverse Events
Sublingual Buprenorphine
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Oral Morphine
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sublingual Buprenorphine
n=33 participants at risk
sublingual buprenorphine: Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
|
Oral Morphine
n=30 participants at risk
oral morphine: Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
|
|---|---|---|
|
Ear and labyrinth disorders
supraglottoplasty
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
0.00%
0/30 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
|
Gastrointestinal disorders
Inguinal hernia repair
|
0.00%
0/33 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
Other adverse events
| Measure |
Sublingual Buprenorphine
n=33 participants at risk
sublingual buprenorphine: Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
|
Oral Morphine
n=30 participants at risk
oral morphine: Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
|
|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
0.00%
0/30 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
|
Skin and subcutaneous tissue disorders
diaper rash
|
15.2%
5/33 • Number of events 5 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
10.0%
3/30 • Number of events 3 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.1%
4/33 • Number of events 5 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
10.0%
3/30 • Number of events 3 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
0.00%
0/30 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
|
Cardiac disorders
Tachycardia
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
0.00%
0/30 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
|
Skin and subcutaneous tissue disorders
Umbilical granuloma
|
3.0%
1/33 • Number of events 1 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
0.00%
0/30 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/33 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
|
Infections and infestations
Respiratory Infection
|
0.00%
0/33 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
|
Gastrointestinal disorders
Gastrointestinal
|
9.1%
3/33 • Number of events 3 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
6.7%
2/30 • Number of events 3 • Adverse events were collected from allocation through discharge from hospital, up to a maximum of 71 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place