NCT03134703

Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome

Terminated Phase 2 Results posted Last updated 3 July 2023

What this trial tests

Phase 2 trial testing Methadone in Neonatal Abstinence Syndrome in 11 participants. Terminated before completion.

Timeline

27 February 2017

Primary endpoint
26 March 2019

27 March 2019

Quick facts

Lead sponsor	Johns Hopkins All Children's Hospital
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	27 February 2017
Primary completion	26 March 2019
Estimated completion	27 March 2019
Sites	1 location across United States

Drugs / interventions tested

• Methadone (METHADONE) — full drug profile →
• Morphine

Conditions studied

• Neonatal Abstinence Syndrome — all drugs for Neonatal Abstinence Syndrome →

Sponsor

Johns Hopkins All Children's Hospital

Who can join

Under 72 Hours, any sex, with Neonatal Abstinence Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Length of Stay (LOS) Primary · 25 days

Compare the LOS of Neonatal Intensive Care Unit (NICU) infants with Neonatal Abstinence Syndrome (NAS) treated with methadone with historical data and a comparison group of NICU NAS infants treated with a different narcotic agent.

Group	Value	95% CI
Methadone Treatment Group	11.3	9 – 15
Comparison Group	16.2	6 – 25

Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ) Secondary · inpatient and at 6-8 weeks of age

The Postpartum Bonding Questionnaire (PBQ) is a self-rating questionnaire designed to detect disorders of the mother-infant relationship. The questionnaire has 25 statements, each with six alternative responses ranging from 0 (always) to 5 (never). For the PBQ, scores are summated for each factor, with a high score indicating concern for bonding. The PBQ yields a total score between 0 to 125. Positive responses are scored from 0 ('always') to 5 ('never'). Negative responses, are scored from 5 ('always') to 0 ('never'). Factor 1 (impaired bonding) is based on 12 questions, with a score range 0

Factor 1 inpatient

Group	Value	95% CI
Methadone Treatment Group	0	0 – 0
Comparison Group	0.4	0 – 2

Factor 2 inpatient

Group	Value	95% CI
Methadone Treatment Group	0	0 – 0
Comparison Group	0	0 – 0

Factor 3 inpatient

Group	Value	95% CI
Methadone Treatment Group	0.6	0 – 1
Comparison Group	1	0 – 2

Factor 4 inpatient

Group	Value	95% CI
Methadone Treatment Group	0	0 – 0
Comparison Group	0	0 – 0

Factor 1 6-8 weeks

Group	Value	95% CI
Methadone Treatment Group	1	1 – 1
Comparison Group	0.5	0 – 1

Factor 2 6-8 weeks

Group	Value	95% CI
Methadone Treatment Group	0	0 – 0
Comparison Group	1	0 – 2

Factor 3 6-8 weeks

Group	Value	95% CI
Methadone Treatment Group	0	0 – 0
Comparison Group	2.5	2 – 3

Factor 4 6-8 weeks

Group	Value	95% CI
Methadone Treatment Group	0	0 – 0
Comparison Group	0	0 – 0

Maternal Depression Measured With The Edinburgh Postnatal Depression Scale (EPDS) Secondary · While inpatient and at 6-8 weeks of age

The Edinburgh Postnatal Depression Scale (EPDS) was developed for screening postpartum women in outpatient, home visiting settings, or at the 6-8 week postpartum examination. The EPDS is a 10-item questionnaire with responses scored 0, 1, 2, or 3 according to increased severity of the symptom. The maximum total score is 30 while the minimum score is 0. A score of 10 or greater, as well as any answer choice other than "never" on question #10 (suicidal thoughts) of the EPDS are indicative of depressive symptomatology.

EPDS inpatient

Group	Value	95% CI
Methadone Treatment Group	0.3	0 – 1
Comparison Group	7.2	1 – 20

EPDS 6-8 weeks

Group	Value	95% CI
Methadone Treatment Group	10	10 – 10
Comparison Group	5.3	1 – 14

Readmission to Hospital Secondary · Within 30 days of discharge

Number of hospital readmissions

Group	Value	95% CI
Methadone Treatment Group	0
Comparison Group	0

Infant Development Secondary · 4, 8 and 12 months of age

Assess the age appropriate infant development at 4, 8 and 12 months of age among the methadone treatment group using the Ages and Stages-based questionnaires (ASQ). The questionnaires are screening tools designed to identify infants at risk for developmental delays through caregivers' provision of quantitative information regarding their infant's development. In the ASQ, higher scores indicate more positive outcomes. The ASQ covers 5 areas of development: communication, gross motor, fine motor, problem solving, and personal-social. Scores for each area should fall between 0-60. Scoring: 0-30

Communication at 4m

Group	Value	95% CI
Methadone Treatment Group	51.7	45 – 60

Gross motor at 4m

Group	Value	95% CI
Methadone Treatment Group	56.7	50 – 60

Fine motor at 4m

Group	Value	95% CI
Methadone Treatment Group	56.7	55 – 60

Problem solving at 4m

Group	Value	95% CI
Methadone Treatment Group	56.7	50 – 60

Personal-social at 4m

Group	Value	95% CI
Methadone Treatment Group	60	60 – 60

Communication at 8m

Group	Value	95% CI
Methadone Treatment Group	60	60 – 60

Gross motor at 8m

Group	Value	95% CI
Methadone Treatment Group	50	50 – 50

Fine motor at 8m

Group	Value	95% CI
Methadone Treatment Group	50	50 – 50

Sponsor's own description

This is a non-randomized, un-blinded feasibility study project comparing the Length of Stay (LOS) of Neonatal Intensive Care Unit (NICU) infants diagnosed with Neonatal Abstinence Syndrome (NAS) treated with methadone with historical data and a comparison group of NICU NAS infants treated with a different narcotic agent.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.