Trial Outcomes & Findings for Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome (NCT NCT02851303)
NCT ID: NCT02851303
Last Updated: 2023-05-24
Results Overview
Number of days in hospital after birth
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
assessed at hospital discharge, approximately 7-30 days
Results posted on
2023-05-24
Participant Flow
Participants were enrolled as dyads during the initial birth hospitalization. Randomization occured at the time of consent to allow for pharmacologic treatment to begin whenever it was deemed medically necessary without the time constraint of needing randomization by the research team. As not all infants required pharmacologic treatment for withdrawal, they dropped out of the study arm.
Participant milestones
| Measure |
Morphine
Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)
Score Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose
Morphine Maintenance/Escalation
* Maintain dose if score 0-8
* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16
* Increase score by 0.06 if score 17-20
Weaning Instructions:
* Maintain on dose 48 hrs before starting weaning
* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12
Re-escalation
* If neonate scores 9-12 re-score as described for initiation,
* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs
* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc
Morphine: Morphine wean protocol as described in arm description
|
Methadone
Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours
Methadone: Methadone wean protocol as described in arm description
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
13
|
|
Overall Study
COMPLETED
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
Baseline characteristics by cohort
| Measure |
Morphine
n=15 Participants
Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)
Score Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose
Morphine Maintenance/Escalation
* Maintain dose if score 0-8
* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16
* Increase score by 0.06 if score 17-20
Weaning Instructions:
* Maintain on dose 48 hrs before starting weaning
* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12
Re-escalation
* If neonate scores 9-12 re-score as described for initiation,
* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs
* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc
Morphine: Morphine wean protocol as described in arm description
|
Methadone
n=13 Participants
Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours
Methadone: Methadone wean protocol as described in arm description
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 weeks
STANDARD_DEVIATION 1.7 • n=5 Participants
|
37.5 weeks
STANDARD_DEVIATION 1.2 • n=7 Participants
|
37.6 weeks
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Age, Customized
Mean age
|
27.8 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
25.4 years
STANDARD_DEVIATION 3.1 • n=7 Participants
|
26.68 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White non-hispanic
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
hispanic
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
native american
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Initiation of prenatal care in first trimester
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Concurrent illicit opioid use
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Concurrent tobacco use
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Concurrent methamphetamine use
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Concurrent benzodiazepine use
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Concurrent alcohol use
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Concurrent SSRI
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Preterm delivery
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Maternal gestational diabetes
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Maternal preeclampsia
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed at hospital discharge, approximately 7-30 daysNumber of days in hospital after birth
Outcome measures
| Measure |
Morphine
n=15 Participants
Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)
Score Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose
Morphine Maintenance/Escalation
* Maintain dose if score 0-8
* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16
* Increase score by 0.06 if score 17-20
Weaning Instructions:
* Maintain on dose 48 hrs before starting weaning
* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12
Re-escalation
* If neonate scores 9-12 re-score as described for initiation,
* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs
* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc
Morphine: Morphine wean protocol as described in arm description
|
Methadone
n=13 Participants
Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours
Methadone: Methadone wean protocol as described in arm description
|
|---|---|---|
|
Length of Hospital Stay
|
17.9 days
Standard Deviation 8.6
|
16.1 days
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: assessed at hospital discharge, approximately 7-30 daysOutcome measures
| Measure |
Morphine
n=15 Participants
Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)
Score Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose
Morphine Maintenance/Escalation
* Maintain dose if score 0-8
* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16
* Increase score by 0.06 if score 17-20
Weaning Instructions:
* Maintain on dose 48 hrs before starting weaning
* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12
Re-escalation
* If neonate scores 9-12 re-score as described for initiation,
* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs
* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc
Morphine: Morphine wean protocol as described in arm description
|
Methadone
n=13 Participants
Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours
Methadone: Methadone wean protocol as described in arm description
|
|---|---|---|
|
Length of Treatment
|
14.7 days
Standard Deviation 9.9
|
12.8 days
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: assessed at hospital discharge, approximately 7-30 daysclonidine
Outcome measures
| Measure |
Morphine
n=15 Participants
Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)
Score Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose
Morphine Maintenance/Escalation
* Maintain dose if score 0-8
* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16
* Increase score by 0.06 if score 17-20
Weaning Instructions:
* Maintain on dose 48 hrs before starting weaning
* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12
Re-escalation
* If neonate scores 9-12 re-score as described for initiation,
* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs
* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc
Morphine: Morphine wean protocol as described in arm description
|
Methadone
n=13 Participants
Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours
Methadone: Methadone wean protocol as described in arm description
|
|---|---|---|
|
Need for Additional Agent to Treat Withdrawal, Determined by Chart Review of Medication Administration Record of Administered Medications for Withdrawal Treatment (Example: Clonidine or Phenobarbital)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: assessed at hospital discharge, approximately 7-30 daysOutcome measures
| Measure |
Morphine
n=15 Participants
Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)
Score Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose
Morphine Maintenance/Escalation
* Maintain dose if score 0-8
* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16
* Increase score by 0.06 if score 17-20
Weaning Instructions:
* Maintain on dose 48 hrs before starting weaning
* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12
Re-escalation
* If neonate scores 9-12 re-score as described for initiation,
* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs
* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc
Morphine: Morphine wean protocol as described in arm description
|
Methadone
n=13 Participants
Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours
Methadone: Methadone wean protocol as described in arm description
|
|---|---|---|
|
Need for Feeding Assistance, Determined by Chart Review of Discharge Summary, Specifically Evaluating for Need for Nasogastric Tube Placement or Peripheral Parenteral Nutrition.
|
11 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: assessed at hospital discharge, approximately 7-30 daysOutcome measures
| Measure |
Morphine
n=15 Participants
Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)
Score Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose
Morphine Maintenance/Escalation
* Maintain dose if score 0-8
* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16
* Increase score by 0.06 if score 17-20
Weaning Instructions:
* Maintain on dose 48 hrs before starting weaning
* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12
Re-escalation
* If neonate scores 9-12 re-score as described for initiation,
* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs
* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc
Morphine: Morphine wean protocol as described in arm description
|
Methadone
n=13 Participants
Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours
Methadone: Methadone wean protocol as described in arm description
|
|---|---|---|
|
Need for NICU Transfer, as Determined by Chart Review of Discharge Summary.
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: assessed at hospital discharge, approximately 7-30 daysAssessed through chart review of discharge summary documentation of method of infant feeding at time of discharge
Outcome measures
| Measure |
Morphine
n=15 Participants
Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)
Score Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose
Morphine Maintenance/Escalation
* Maintain dose if score 0-8
* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16
* Increase score by 0.06 if score 17-20
Weaning Instructions:
* Maintain on dose 48 hrs before starting weaning
* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12
Re-escalation
* If neonate scores 9-12 re-score as described for initiation,
* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs
* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc
Morphine: Morphine wean protocol as described in arm description
|
Methadone
n=13 Participants
Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours
Methadone: Methadone wean protocol as described in arm description
|
|---|---|---|
|
Breastfeeding Initiation and Continuation at Hospital Discharge
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: assessed at hospital discharge, approximately 7-30 daysOutcome measures
| Measure |
Morphine
n=15 Participants
Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)
Score Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose
Morphine Maintenance/Escalation
* Maintain dose if score 0-8
* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16
* Increase score by 0.06 if score 17-20
Weaning Instructions:
* Maintain on dose 48 hrs before starting weaning
* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12
Re-escalation
* If neonate scores 9-12 re-score as described for initiation,
* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs
* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc
Morphine: Morphine wean protocol as described in arm description
|
Methadone
n=13 Participants
Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours
Methadone: Methadone wean protocol as described in arm description
|
|---|---|---|
|
Total Morphine Equivalent Dose Received
|
9.86 morphine equivalents mg
Standard Deviation 12.92
|
33.0 morphine equivalents mg
Standard Deviation 17.49
|
Adverse Events
Morphine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methadone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Morphine
n=15 participants at risk
Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)
Score Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose
Morphine Maintenance/Escalation
* Maintain dose if score 0-8
* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16
* Increase score by 0.06 if score 17-20
Weaning Instructions:
* Maintain on dose 48 hrs before starting weaning
* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12
Re-escalation
* If neonate scores 9-12 re-score as described for initiation,
* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs
* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc
Morphine: Morphine wean protocol as described in arm description
Adverse events were recorded only for infants of each dyad.
|
Methadone
n=13 participants at risk
Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours
Methadone: Methadone wean protocol as described in arm description
Adverse events were recorded only for infants of each dyad.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
High level of care transfer
|
0.00%
0/15 • Collected during initial hospitalization following birth for entire length of hospital stay on infants of dyads only. No infant adverse events following hospital discharge were collected. No maternal adverse events were examined/collected.
|
23.1%
3/13 • Number of events 3 • Collected during initial hospitalization following birth for entire length of hospital stay on infants of dyads only. No infant adverse events following hospital discharge were collected. No maternal adverse events were examined/collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place