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Trial · NCT03134703

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYLength of Stay (LOS)25 daysStudy 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.daysMEAN
SECONDARYMaternal 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 scaleMEAN
SECONDARYMaternal 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 scaleMEAN
SECONDARYReadmission to HospitalWithin 30 days of dischargeReadmissions to the hospital within 30 days for NAS-related reasons.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYBreast Milk30 days of ageStudy closed prematurely due to poor accrual and no analysis was completed. Incidence of providing breast milk at 30 days was not collected.
SECONDARYInfant Development4, 8 and 12 months of ageInfant 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 scaleMEAN
SECONDARYScreened vs. EligibleAfter 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.
SECONDARYAttrition RateAfter 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.
SECONDARYHome CareAfter accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trialStudy closed prematurely due to poor accrual and no analysis was completed. Proportion of mothers data was not collected.
SECONDARYReadiness of Mothers to Assess InfantAfter 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.
SECONDARYCompliance With Pediatrician VisitsAfter 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. Compliance rate was not assessed/collected.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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