Postpartum Care in the NICU Multi-Site Breastfeeding

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.