Clinical trial NCT03013660: Supporting Mothers of Preterm Infants
Official title: Supporting Mothers of Preterm Infants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreTerm Birth
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Harvard School of Public Health (HSPH)
First posted: 2017-01-06
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. mothers who gave (preterm) birth at the study hospitals 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 hospitals 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.

Primary outcomes:
measure: Proportion of days mothers practice STSC
timeFrame: Captured in hospital records during the first 1-3 weeks after enrollment
Secondary outcomes:
measure: Exclusive breastfeeding duration
timeFrame: Self-reported after 3 months
measure: Change in head circumference
timeFrame: Head circumference measured at birth (time 0) and after 3 months
measure: General infant development composite score (based on 5 age-appropriate milestones)
timeFrame: Reported by mother at 3 month survey
measure: Mental/emotional wellbeing of mother
timeFrame: Self-reported after 3 months
measure: Mother-infant attachment
timeFrame: Self-reported after 3 months
measure: Readmissions
timeFrame: Self-reported after 3 months
measure: Cost and cost-effectiveness
timeFrame: Within 3 months of discharge
measure: Any breastfeeding at 3mo
timeFrame: Self-reported after 3 months
measure: Breastfeeding initiation
timeFrame: Captured in hospital records during first 1-3 weeks after enrollment
measure: Duration of NICU stay
timeFrame: Captured in hospital records during the first 1-3 weeks after enrollment
measure: Change in weight-for-age z-score
timeFrame: Change between measurement at birth (time 0) and after 3 months after discharge
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Lowell
country: United States
facility: Lowell General Hospital
state: Massachusetts
Study officials:
References: