Trial · NCT07881731
Postpartum Care in the NICU Multi-Site Breastfeeding
NCT07881731, Not applicable, Not yet recruiting, Children's Hospital of Philadelphia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Postpartum Care in the NICU Multi-Site Breastfeeding. Trials, record NCT07881731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07881731
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Postpartum Care in the NICU Multi-Site Breastfeeding
- NCT number
- NCT07881731
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 640 participants, estimated
- Lead sponsor
- Children's Hospital of Philadelphia
- Conditions
Postpartum Complication, Postpartum, PTSD, PTSD (Childbirth-Related), Infant Feeding Practices, Breastfeeding Education, Breastfeeding, Health Related Quality of Life, LACTATION IN MOTHERS WITH PREMATURE NEWBORNS
- Interventions
- NICU-informed postpartum doula support
- First posted
- 2026-10-19
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Breastfeeding and Lactation Rates at 6 Months Postpartum | The outcome for Aim 1 will be assessed at 6 months postpartum. | The primary endpoint is to assesses the effectiveness of the PeliCaN doula intervention in improving breastfeeding and lactation outcomes at 6 months postpartum across two components: 1. Any breastfeeding or provision of expressed maternal breast milk to the infant at 6 months postpartum (Yes/No), ascertained by participant self-report on the 6-month follow-up survey. 2. Duration of any breastfeeding or human milk feeding, measured continuously in months. Participants who have weaned by the 6-month survey report the infant's age in months at the time of weaning. Ascertained by self-report on the 6-month follow-up survey. Both components will be examined by study arm (intervention vs. usual care) and by site. |
| Secondary | Postpartum Health-Related Quality of Life (CDC HRQoL-14) | 6 months postpartum | Health-related quality of life assessed using the CDC Healthy Days Measure (HRQoL-14), a 14-item instrument combining the 4-item Healthy Days Core Module with the Activity Limitations Module (5 items) and Healthy Days Symptoms Module (5 items). The core module assesses self-rated general health, days with poor physical health, days with poor mental health, and days of activity limitation in the past 30 days. Supplemental items assess pain, depression, anxiety, sleeplessness, vitality, and the cause, duration, and severity of activity limitations. |
| Secondary | Post-Traumatic Stress Disorder Symptoms (PCL-5) | 6 months postpartum | PTSD symptom severity assessed using the PTSD Checklist for DSM-5 (PCL-5), a validated 20-item self-report instrument scored 0-80, with higher scores indicating greater symptom burden. Examined as a continuous total score. A threshold score of ≥31 is used as a secondary indicator of probable PTSD diagnosis. Administered at 6 months postpartum. |
| Secondary | Implementation Assessment: Feasibility (FIM) | End of study, approximately 3 years | Feasibility assessed across two components: (1) Doula, NICU nurse, and lactation consultant perceptions that the PeliCaN intervention is suitable for everyday use in the NICU, measured using the Feasibility of Intervention Measure (FIM), a validated 4-item scale scored on a 5-point Likert scale (mean score range 1-5; higher scores indicate greater feasibility), administered via structured survey to all three stakeholder groups; and (2) average time spent by each doula per enrolled mother per week dedicated specifically to lactation support, in minutes, derived from the REDCap Doula Tracking Log. |
| Secondary | Implementation Assessment: Acceptability (AIM) | End of study, approximately 3 years | Acceptability assessed using the Acceptability of Intervention Measure (AIM), a validated 4-item self-report scale measuring perceptions that the content of the PeliCaN doula intervention is satisfactory, scored on a 5-point Likert scale (mean score range 1-5; higher scores indicate greater acceptability). Administered via a survey to doulas, NICU nurses, and NICU lactation consultants. Results will be examined by site and by respondent role and will be supplemented by semi-structured qualitative interviews with a purposive sample of intervention participants, doulas, and NICU clinical staff conducted after the intervention period. |
| Secondary | Implementation Assessment: Fidelity of Intervention | End of study, approximately 3 years | Intervention fidelity will be measured as the average percentage of completed weekly doula contacts among all enrolled intervention participants across the 6-month intervention period. A weekly contact is defined as any documented in-person, phone, or video encounter between the doula and the participant logged in the REDCap Doula Tracking Log. Fidelity will be calculated by site as the proportion of expected weekly contacts completed, averaged across all enrolled participants and all weeks of the intervention period. |
| Other | Breastfeeding Continuation as Desired by Participant | 6 months postpartum | Binary (Yes/No) indicator of whether the participant breastfed or provided expressed maternal breast milk to her infant for as long as she desired, ascertained by self-report on the 6-month follow-up survey. This measure captures lactation continuation independent of absolute duration, recognizing that breastfeeding success is self-defined. Examined alongside duration of breastfeeding (in months, for participants who have weaned) and proportion of infant feeds that are maternal milk (for participants still providing breast milk at 6 months), together providing a comprehensive picture of lactation trajectory and achievement of maternal feeding goals. |
| Other | Mother-Infant Bonding (Modified Postpartum Bonding Questionnaire) | 6 months postpartum | Mother-infant bonding will be assessed using the Modified Postpartum Bonding Questionnaire (Modified PBQ), a validated self-report measure of the quality of the early mother-infant relationship. Administered on the 6-month follow-up survey. Both the continuous total score and subscale scores will be examined. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers9
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT07881731
GET https://conductscience.org/api/trials/v1/NCT07881731/registered