Supporting Mothers of Preterm Infants: A Randomized Controlled Trial

PreTerm Birth Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02953795
• Other study ID #: IRB15-3993
• Status: Not yet recruiting
• Phase: N/A
• First received: October 31, 2016
• Last updated: November 1, 2016
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: November 2016
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 a hospital in Boston, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: November 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. mothers who gave (preterm) birth at the study hospital as well mothers who gave birth elsewhere (e.g. at a hospital without a high-level NICU) but whose babies were immediately transferred to the study hospital for preterm care after birth.

2. mothers of children born between 30 and 36 weeks of gestation without any major complications requiring additional or special medical care for mother and child

Exclusion Criteria:

1. under the age of 18 years

2. not currently covered by Medicaid

3. unable to speak or understand English or Spanish

4. not residents of the state of Massachusetts

5. any of the following complications: HIV infection, active tuberculosis, are undergoing radiation therapy, recent breast surgery, indications of illicit drug use currently or during pregnancy (from meconium or cord sample, or urine test), or other contraindications for breastfeeding; or their baby has congenital, surgical, or cardiac anomalies. Note that enrolled women who are identified as using illicit drugs after enrollment will be removed from the study per hospital protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Premature Birth
• PreTerm Birth

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Tufts Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of days mothers practice STSC	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)	Captured in hospital records during the first 1-3 weeks after enrollment	No
Primary	Any breastfeeding	Self-reported	Fraction of mothers still breastfeeding (does not need to be exclusive) their infants at 3 months	No
Primary	Breastfeeding initiation	Fraction of mothers who ever begin breastfeeding	Captured in hospital records during first 1-3 weeks after enrollment	No
Primary	Duration of NICU stay	Number of days infants stay in the NICU before discharge	Captured in hospital records during the first 1-3 weeks after enrollment	No
Primary	Change in weight-for-age z-score	Difference between birthweight z-score and weight-for-(corrected)-age z-score of infant	Change in weight measured at birth (time 0) and after 3 months from discharge	No
Secondary	Exclusive breastfeeding duration	Mean weeks of exclusive breastfeeding duration among enrolled mothers	Self-reported after 3 months	No
Secondary	Change in head circumference	Difference between head circumference z-score at birth and at 3 months post-discharge	Head circumference measured at birth (time 0) and after 3 months	No
Secondary	Infant development	Infant development as measured by motor, communication, and socioemotional scores	Reported by mother at 3 month survey	No
Secondary	Mental/emotional wellbeing of mother	Mental/emotional wellbeing score of enrolled mothers based on Edinburgh Scale of Postpartum Depression	Self-reported after 3 months	No
Secondary	Mother-infant attachment	Attachment score between enrolled mothers and their preterm infant based on Postpartum Bonding Questionnaire	Self-reported after 3 months	No
Secondary	Readmissions	Fraction of infants who were readmitted to the hospital post-discharge and the mean duration of their stay	Self-reported after 3 months	No
Secondary	Cost and cost-effectiveness	Total cost of infant's care, including both hospital and out-of-pocket spending	Within 3 months of discharge	No