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NCT03836430 · ClinicalTrials.gov registry record · NA
The Impact of a Newborn Behavioral Intervention on the Mental Health of Mothers With Late Pre-Term Infants
A NA study of Postpartum Depression and Infant Development, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 208
- Enrollment target
- 1
- Study location
NCT03836430: Completed NA study of Postpartum Depression and Infant Development, sponsored by Brigham and Women's Hospital.
NCT03836430 is a NA study of Postpartum Depression and Infant Development that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 208 participants, below the 471-participant average among 47 other Postpartum Depression trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03836430, a NA study of Postpartum Depression and Infant Development, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 208 participants
- Enrollment target
- 1
- Study location
Study Summary
Preterm birth is a serious public health issue, affecting 10% of all births in the US alone. Three quarters of these infants are born between 34 0/7 and 36 6⁄7 weeks' gestation or late-preterm (LP). Mothers of LP infants are at increased risk for postpartum stress, depression and mother-infant interaction problems posing significant risks for infant development. Our proposed project will advance the fields of maternal and child health by examining the impact of the Newborn Behavioral Observations Family Wellness (NBO-FW), a dyadic, two generational intervention targeting maternal wellbeing and early mother-infant relations in families of LP born infants. The NBO-FW is a 12week preventative intervention aimed at promoting maternal mental health and positive parenting. It is based on the highly successful NBO intervention developed by our team and applied across five continents, but with important new elements targeting maternal mental health and the needs of high-risk LP infants and their families. Participants will consist of 200 first-time mothers and their LP infants (100 intervention and 100 control dyads) born at Brigham and Women's Hospital (BWH), an urban teaching hospital of Harvard Medical School and the largest maternity care provider in Boston. Data will be collected at three time points: during the birth hospitalization, at a follow-up visit at 4-6 weeks corrected gestational age, and at a further visit 10-12 weeks after birth. Outcomes will include standardized measures of maternal stress, depression, parenting confidence, and observed mother-infant interaction. Information about infant health care practices and maternal/infant health will also be recorded. We hypothesize that, compared to mothers in the care as usual control group, first-time mothers of LP infants who receive the NBO-FW will demonstrate a) lower levels of stress and depression, b) greater parenting confidence, c) higher quality interactions with their infants (e.g., positive affect, sen
Primary Outcome
Center for Epidemiological Studies Depression Scale-Revised (CESD-R). Scale is 0 - 36, where higher scores indicate higher levels of depressive symptoms.
Conditions Studied
Interventions
- BEHAVIORAL Newborn Behavioral Observation-Family Wellness (NBO-FW)
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2022-05-05 |
| Phase | NA |
What the finished NCT03836430 record still lists
NCT03836430 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 471-participant average among 47 other Postpartum Depression trials with a reported enrollment target (56% lower).
The record links to 3 conditions, with Postpartum Depression appearing as the primary indexed condition, and to 1 intervention - of which Newborn Behavioral Observation-Family Wellness (NBO-FW) is the first listed.
NCT03836430 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03836430 about?
NCT03836430 is a clinical study titled "The Impact of a Newborn Behavioral Intervention on the Mental Health of Mothers With Late Pre-Term Infants". Preterm birth is a serious public health issue, affecting 10% of all births in the US alone. Three quarters of these infants are born between 34 0/7 and 36 6⁄7 weeks' gestation or late-preterm (LP). Mothers of LP infants are at increased risk for postpartum stress, depression and mother-infant inter...
What is the current status of trial NCT03836430?
This trial is currently completed. It is a NA study. The enrollment target is 208 participants. The study started on 2019-08-01. Estimated completion is 2022-05-05.
What conditions does trial NCT03836430 study?
This clinical trial studies the following conditions: Postpartum Depression, Infant Development, Preterm Infant.
What interventions are being tested in trial NCT03836430?
The interventions under investigation include: Newborn Behavioral Observation-Family Wellness (NBO-FW) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03836430?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03836430 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postpartum Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03836430's enrollment target sits among peer trials
208 18th of 47 higher than 30 of 47 other Postpartum Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postpartum Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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