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NCT03013660 · ClinicalTrials.gov registry record · NA
Supporting Mothers of Preterm Infants
A NA study of Preterm Birth, sponsored by Tufts Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 68
- Enrollment target
- 2
- Study locations
NCT03013660: Completed NA study of Preterm Birth, sponsored by Tufts Medical Center.
NCT03013660 is a NA study of Preterm Birth that has completed, run by Tufts Medical Center. The registered enrollment target is 68 participants, below the 4,407-participant average among 39 other Preterm Birth trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03013660, a NA study of Preterm Birth, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 68 participants
- Enrollment target
- 2
- Study locations
Study Summary
Preterm birth is the leading contributor to mortality among children younger than 5 years. One effective and inexpensive intervention is providing skin-to-skin care (STSC) whereby the mother of a preterm baby provides skin-to-skin contact to the newborn for at least a few hours, ideally every day. This intervention can make breastfeeding easier and can improve the health and development of the baby. Unfortunately, despite the large health benefits, mothers in low-resource communities are often unable to practice STSC due to a range of institutional and economic barriers. STSC requires substantial time and financial commitments from mothers; they must travel from home each day to the hospital to engage in STSC and provide expressed breast milk. Low-income women with access only to limited federally provided unpaid family leave may have to choose between returning to work while their baby is in the NICU and being able to stay at home with their newborn after discharge from the NICU. Families of preterm infants also face direct financial costs of practicing STSC and breastfeeding (such as fees for parking and childcare for older children). This trial aims to examine the impact of providing additional support to low-income mothers of babies born preterm in 2 hospitals in Massachusetts to help them provide STSC. Half of the participants will be randomized to receive an additional financial support intervention while their infant is in the NICU. The study will examine how this intervention impacts mothers' health behavior while their child is in the NICU and up to three months after. Most of the current and past policy efforts to increase STSC have focused on the delivery of STSC at hospitals, focusing on supply-side related challenges such as the lack of trained and informed staff. However, interventions that focus exclusively on hospitals are unlikely to be sufficient for low-income women if there are significant opportunity costs or transportation costs to simply be
Primary Outcome
Number of days enrolled mothers practice STSC divided by the total number of days their infant is stable in the NICU (count starts after enrollment)
Conditions Studied
Interventions
- OTHER Limited Financial Support
Study Locations (2)
Massachusetts
- Tufts Medical Center - Boston
- Lowell General Hospital - Lowell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2017-01 |
| Est. Completion | 2018-11-21 |
| Phase | NA |
What the finished NCT03013660 record still lists
NCT03013660 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 4,407-participant average among 39 other Preterm Birth trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Preterm Birth appearing as the primary indexed condition, and to 1 intervention - of which Limited Financial Support is the first listed.
NCT03013660 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03013660 about?
NCT03013660 is a clinical study titled "Supporting Mothers of Preterm Infants". Preterm birth is the leading contributor to mortality among children younger than 5 years. One effective and inexpensive intervention is providing skin-to-skin care (STSC) whereby the mother of a preterm baby provides skin-to-skin contact to the newborn for at least a few hours, ideally every day. T...
What is the current status of trial NCT03013660?
This trial is currently completed. It is a NA study. The enrollment target is 68 participants. The study started on 2017-01. Estimated completion is 2018-11-21.
What conditions does trial NCT03013660 study?
This clinical trial studies the following conditions: Preterm Birth.
What interventions are being tested in trial NCT03013660?
The interventions under investigation include: Limited Financial Support (OTHER).
Who is sponsoring clinical trial NCT03013660?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03013660 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03013660's enrollment target sits among peer trials
68 30th of 39 higher than 10 of 39 other Preterm Birth trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Preterm Birth 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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