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Supporting Mothers of Preterm Infants

NCT03013660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2019-07-09

No results posted yet for this 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 being present at the hospital. This study aims to provide more evidence to determine whether removing these financial barriers has the potential to mitigate the poor outcomes of preterm babies born to lower socioeconomic status households.

Conditions

Interventions

OTHER

Limited Financial Support

Subjects randomized to this arm will be contacted to be informed that they are eligible to receive a weekly financial transfer to help them spend more time with their baby at the NICU. The intervention participants will be eligible to receive this transfer every 7 days, starting on the day of enrollment.

Sponsors & Collaborators

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • Tufts Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-07-05
Completion
2018-11-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03013660 on ClinicalTrials.gov