An interventional study of NICU-informed postpartum doula support in Postpartum Complication, Postpartum and PTSD, sponsored by Children's Hospital of Philadelphia. Not yet recruiting at 11 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Health services research
Parents of infants in the neonatal intensive care unit (NICU) face unique barriers to long-term breastfeeding and lactation. The physical and emotional demands of having a critically ill or premature newborn combined with the stress, sleep deprivation, and separation inherent to the NICU environment make it difficult for many mothers to sustain breastfeeding and lactation, even when they want to. At the same time, NICU mothers are at elevated risk for post-traumatic stress disorder (PTSD) and poor health-related quality of life, which can further undermine lactation success and overall maternal wellbeing.
PeliCaN Multi-Site Breastfeeding tests whether a trained postpartum doula, working directly in the NICU can improve breastfeeding and lactation outcomes and support maternal mental health through 6 months postpartum. Participants are enrolled during their infant's NICU hospitalization to receive either doula support or standard care, depending on the study site condition at the time of enrollment (control vs. intervention). Mothers in the intervention group will receive lactation education and support, and emotional and informational support from a NICU-informed doula for up to 6 months. Mothers in the usual care group receive standard NICU clinical care, including access to NICU lactation consultants, without study doula support.
All participants complete surveys at enrollment and at 6 months postpartum covering infant feeding practices, maternal mental health, and demographic characteristics. The study asks two primary questions: (1) Does NICU-informed postpartum doula support improve breastfeeding and lactation rates at 6 months? (2) Does doula support improve health-related quality of life and reduce post-traumatic stress disorder symptoms at 6 months? A subset of intervention participants, NICU staff, and lactation consultants will also participate in qualitative interviews and brief implementation surveys to assess how well the doula program works in practice across participating sites.
Background and Significance:
Breastfeeding and the provision of breastmilk have well-documented health benefits for both infants and mothers, yet rates of long-term breastfeeding continuation remain disproportionately low among families whose newborns require NICU hospitalization. Premature and critically ill infants depend heavily on human milk for immune protection and neurodevelopmental support, yet the NICU environment itself creates formidable barriers to lactation: physical separation from the infant, disrupted skin-to-skin contact, the psychological burden of traumatic birth, clinical complexity, and the all-consuming nature of NICU caregiving leave many motivated mothers unable to sustain the pumping and breastfeeding routines that lactation requires. These challenges are compounded by the high rates of postpartum depression and PTSD that characterize the NICU parent experience, both of which are independently linked to earlier breastfeeding cessation, and by socioeconomic and structural inequities that make sustained lactation difficult after NICU discharge.
Intervention:
The PeliCaN Breastfeeding intervention deploys trained, NICU-informed postpartum doulas as a sustained bridge between the NICU care environment and the community supports that mothers need to breastfeed and provide breastmilk to their infants successfully and maintain their own health through the postpartum period. A distinguishing feature of this intervention is its partnership with Breastfeeding Awareness \& Empowerment (BAE), a Philadelphia-based community organization specializing in maternal health and lactation equity. BAE plays an active role throughout the study: advising on culturally responsive participant engagement strategies, adapting intervention protocols to reflect the lived experiences of the families served, providing parent support groups, supporting doula training and wellness, and participating in quarterly quality improvement meetings to ensure the intervention remains family-centered as it scales across sites.
Doulas will initiate in-person contact at the infant's bedside within 3 days of enrollment, targeting first contact by 10 days postpartum. Weekly contact will take place in person during the NICU stay and virtually following discharge for up to 6 months postpartum. Doula support is organized around five domains: lactation education and hands-on support, emotional, informational, and instrumental support, and coordination of postpartum mental healthcare including scheduling, referrals, and care transitions. All doula encounters are documented in a structured tracking log capturing discussion domains, physical activities, resources provided, contact attempts, and time spent with participants.
Study Design:
This study employs a Type 1 Hybrid Effectiveness-Implementation stepped-wedge cluster randomized controlled trial and will take place across 10 NICUs in the Children's Hospital of Philadelphia Newborn Care Network. Rather than randomizing individual participants, the NICU site is the unit of randomization: all sites begin as usual care (control) sites and cross over to the intervention at staggered, randomly assigned time points over the course of the study. This design is well-suited to the NICU setting, where it is preferable for all sites to eventually offer the intervention, and where secular trends in clinical practice can be controlled through the stepped-wedge design. A 3-month washout period between the usual care and intervention phases at each site ensures that all usual care participants have completed their first 12 postpartum weeks before their site transitions, protecting the integrity of the between-arm comparison.
Approximately 640 participants will be enrolled (320 usual care / 320 intervention). Eligible participants are postpartum individuals within 2 weeks of delivery with an infant born less than 34 weeks gestational age who intend to breastfeed or provide expressed breast milk to their infant. The study is expected to span approximately 4 years.
Study Conditions:
Participants enrolled during the usual care phase receive standard family-centered NICU care available at their site, which typically includes access to lactation consultants, social workers or psychosocial support, and bedside nursing support. The degree to which these services are available varies across sites and represents real-world usual care. No study doula will be assigned during this phase.
Participants enrolled during the intervention phase receive all standard clinical care plus the structured PeliCaN doula breastfeeding support program. Following infant NICU discharge, doula contact transitions to a virtual format and continues up to 6 months postpartum, ensuring continuity of support beyond the NICU walls.
Aims:
Aim 1 (Primary Effectiveness): Determine whether NICU-informed postpartum doula support increases breastfeeding and lactation rates at 6 months postpartum relative to usual care.
Aim 2 (Secondary Effectiveness): Determine whether the intervention improves health-related quality of life and reduces PTSD symptom burden at 6 months postpartum.
Aim 3 (Implementation): Characterize the feasibility, acceptability, and fidelity of delivering the PeliCaN intervention across diverse NICU settings through a prospective mixed-methods implementation evaluation.
Data Collection:
All participants will complete baseline surveys at enrollment and at 6 months postpartum covering infant feeding practices, maternal mental health, and demographic characteristics. Electronic medical records for both the mother and infant will be reviewed for health outcomes, clinical covariates, and potential effect modifiers, with participant consent obtained at enrollment.
The Aim 3 implementation evaluation will employ both quantitative and qualitative methods. A sample of NICU nurses and lactation consultants will complete brief structured surveys designed to capture their perspectives on the intervention's fit within the NICU workflow. Semi-structured qualitative interviews (30-60 minutes) will be conducted virtually in English or Spanish with a purposive sample of mothers who received the intervention, timed 3-6 months after the 6-month follow-up survey to allow for reflective distance. Interviews with NICU nurses and lactation consultants occur after the intervention period concludes at each site. All interviews will be audio-recorded and transcribed by an independent HIPAA-certified transcription service, conducted by interviewers trained in qualitative methods, and guided by an open-ended protocol focused on feasibility and acceptability.
Significance:
The PeliCaN Breastfeeding study addresses a critical and largely unmet need: sustained, culturally responsive lactation and postpartum support for NICU families during and after one of the most demanding experiences of early parenthood. By embedding the intervention within a real-world multi-site NICU network, partnering with a community lactation equity organization, and integrating implementation science methods from the outset, this study is designed to produce findings that can inform immediate clinical translation and health system adoption across diverse NICU settings.
2,284 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 557 are open to participants now.
This study's planned enrollment of 640 is above the median of 70 across 1,897 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Children's Hospital of Philadelphia is the lead sponsor of 488 studies on the registry; 91 are open to participants now.
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Exclusion Criteria:
Subjects that do not meet all of the enrollment criteria may not be enrolled.
Other: NICU-informed postpartum doula support
Intervention participants will receive support from a trained NICU-informed postpartum doula for up to 6 months across four domains: 1. Lactation Consultant Coordination: Doulas will review and reinforce NICU lactation consultant recommendations and facilitate continuity of lactation support through discharge. 2. Pumping Assistance: Doulas will provide hands-on guidance on pump settings, flange fitting, and hand expression; support adherence to pumping schedules; assist with milk tracking, storage, and transport; and provide each participant with a fitted pumping bra. 3. Emotional Support: Doulas will provide reassurance and emotional support throughout the NICU stay, promote bonding practices including skin-to-skin contact, and facilitate mental health referrals when needed. 4. Nutritional Support: Doulas will provide lactation nutrition education and connect participants with community resources including food banks and WIC.
Also known as: Patient resource navigator support, Doula
Breastfeeding and Lactation Rates 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.
Time frame: The outcome for Aim 1 will be assessed at 6 months postpartum.
Postpartum Health-Related Quality of Life (CDC HRQoL-14)
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.
Time frame: 6 months postpartum
Post-Traumatic Stress Disorder Symptoms (PCL-5)
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.
Time frame: 6 months postpartum
Implementation Assessment: Feasibility (FIM)
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.
Time frame: End of study, approximately 3 years
Implementation Assessment: Acceptability (AIM)
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.
Time frame: End of study, approximately 3 years
Implementation Assessment: Fidelity of Intervention
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.
Time frame: End of study, approximately 3 years
Breastfeeding Continuation as Desired by Participant
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.
Time frame: 6 months postpartum
Mother-Infant Bonding (Modified Postpartum Bonding Questionnaire)
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.
Time frame: 6 months postpartum
Plan to share: Yes — Aggregate, de-identified summary data underlying findings reported in primary publications will be made available to qualified investigators upon reasonable written request to the Principal Investigator. Requests will be reviewed by the study team and approved at the discretion of the PI, contingent upon execution of a data use agreement specifying permissible uses, data security requirements, and publication coordination expectations. Researchers interested in accessing summary data for secondary analysis or replication purposes may submit inquiries to the Principal Investigator at burrish@chop.edu.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
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Stress Disorders, Post-Traumatic →
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