Trial · NCT03134703
Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome
NCT03134703, Phase 2, Terminated, Johns Hopkins All Children's Hospital; results first posted 2020-05-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome. Trials, record NCT03134703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03134703
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome
- NCT number
- NCT03134703
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Conditions
- Neonatal Abstinence Syndrome
- Interventions
- Methadone, Morphine
- First posted
- 2017-05-01
- Last updated
- 2023-07-03
- Results first posted
- 2020-05-19
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Length of Stay (LOS) | 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. |
| Secondary | Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ) | 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 0-60 (0-11=normal; 12 \& above=high). Factor 2 (rejection \& anger) is based on 7 questions with a score range 0-35 (0-16=normal; 17 \& above=high). Factor 3 (anxiety about care) is based on 4 questions with a score range 0-20 (0-9=normal; 10 \& above =high). Factor 4 (risk of abuse) is based on 2 questions, with a score range 0-10 (0-2=normal; 3 \& above =high). |
| Secondary | Maternal Depression Measured With The Edinburgh Postnatal Depression Scale (EPDS) | 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. |
| Secondary | Readmission to Hospital | Within 30 days of discharge | Number of hospital readmissions |
| Secondary | Breast Milk | 30 days of age | Compare the incidence of providing breast milk (\> 50% of nutritional needs) at 30 days of age between methadone treated and non-treated infants |
| Secondary | Infant Development | 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 = further assessment with a professional may be needed 30-40 = learning activities \& monitoring are indicated 45-60 = child development appears to be on schedule |
| Secondary | Screened vs. Eligible | After accrual of the first 50% of participants & after accrual of the second 50% of participants, and at completion of the trial. | Determine the response percentage of mothers who are screened as eligible by PAR officials and who agree to participate in the demonstration project |
| Secondary | Attrition Rate | After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial. | Assess the drop out percentage of mothers who agree to participate but do not follow through with home discharge for continued care |
| Secondary | Home Care | After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial | Quantitate the proportion of mothers who feel comfortable with home care of their infant at discharge |
| Secondary | Readiness of Mothers to Assess Infant | After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial. | Monitor the readiness of mothers to assess infant on 3 to 4 hours intervals while at home |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Length of Stay (LOS) | 25 days | Study closed prematurely due to poor accrual. There were 3 screen fails (did not receive study drug) in the methadone treatment group, therefore LOS was not calculated for those participants. | days | MEAN |
| SECONDARY | Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ) | inpatient and at 6-8 weeks of age | Data analysis was not completed. Results shown below are means for each group, note that many participants replied on the extremes of the answer range (e.g. always or never), which yields very low total scores for each factor. | score on a scale | MEAN |
| SECONDARY | Maternal Depression Measured With The Edinburgh Postnatal Depression Scale (EPDS) | While inpatient and at 6-8 weeks of age | Data analysis was not completed. Results shown below are average scores on the EPDS scale for each group. 9 participants completed the EPDS while in patient, and 4 participants completed the questionnaire at the 6-8 weeks time point. | score on a scale | MEAN |
| SECONDARY | Readmission to Hospital | Within 30 days of discharge | Readmissions to the hospital within 30 days for NAS-related reasons. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Breast Milk | 30 days of age | Study closed prematurely due to poor accrual and no analysis was completed. Incidence of providing breast milk at 30 days was not collected. | ||
| SECONDARY | Infant Development | 4, 8 and 12 months of age | Infant development assessed only on those participants who received study drug (methadone arm). 3 participants completed the ASQ at 4 months, 1 participant at 8 months, and 1 participant at 12 months. | score on a scale | MEAN |
| SECONDARY | Screened vs. Eligible | After accrual of the first 50% of participants & after accrual of the second 50% of participants, and at completion of the trial. | Study closed prematurely due to poor accrual and no analysis was completed. Response percentage was not collected. | ||
| SECONDARY | Attrition Rate | After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial. | Study closed prematurely due to poor accrual and no analysis was completed. Drop out percentage was not collected. | ||
| SECONDARY | Home Care | After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial | Study closed prematurely due to poor accrual and no analysis was completed. Proportion of mothers data was not collected. | ||
| SECONDARY | Readiness of Mothers to Assess Infant | After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial. | Study closed prematurely due to poor accrual and no analysis was completed. Readiness of mothers was not assessed/collected. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Length of Stay (LOS) | Methadone Treatment Group | 11.3 | Full Range 9 to 15 | days | |
| Length of Stay (LOS) | Comparison Group | 16.2 | Full Range 6 to 25 | days | |
| Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ) | Methadone Treatment Group | Factor 1 inpatient | 0 | Full Range 0 to 0 | score on a scale |
| Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ) | Comparison Group | Factor 1 inpatient | 0.4 | Full Range 0 to 2 | score on a scale |
| Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ) | Methadone Treatment Group | Factor 2 inpatient | 0 | Full Range 0 to 0 | score on a scale |
| Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ) | Comparison Group | Factor 2 inpatient | 0 | Full Range 0 to 0 | score on a scale |
| Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ) | Methadone Treatment Group | Factor 3 inpatient | 0.6 | Full Range 0 to 1 | score on a scale |
| Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ) | Comparison Group | Factor 3 inpatient | 1 | Full Range 0 to 2 | score on a scale |
| Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ) | Methadone Treatment Group | Factor 4 inpatient | 0 | Full Range 0 to 0 | score on a scale |
| Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ) | Comparison Group | Factor 4 inpatient | 0 | Full Range 0 to 0 | score on a scale |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methadone Treatment Group | 6 | |
| Overall Study | STARTED | Comparison Group | 5 | |
| Overall Study | COMPLETED | Methadone Treatment Group | 0 | |
| Overall Study | COMPLETED | Comparison Group | 3 | |
| Overall Study | NOT COMPLETED | Methadone Treatment Group | 6 | |
| Overall Study | NOT COMPLETED | Comparison Group | 2 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methadone Treatment Group | 0 | 6 |
| Total, all-cause mortality | Comparison Group | 0 | 0 |
| Total, other adverse events | Methadone Treatment Group | 0 | 6 |
| Total, other adverse events | Comparison Group | 0 | 0 |
| Total, serious adverse events | Methadone Treatment Group | 0 | 6 |
| Total, serious adverse events | Comparison Group | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Methadone Treatment Group vs Comparison Group: Readmission to Hospital |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03134703
GET https://conductscience.org/api/trials/v1/NCT03134703/results?page=2