Supporting Mothers of Preterm Infants
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/14/2017 |
| Start Date: | January 2017 |
| End Date: | November 2018 |
| Contact: | Sunita Pereira, MD |
| Email: | speirera@tuftsmedicalcenter.org |
| Phone: | 6176364197 |
Supporting Mothers of Preterm Infants: A Randomized Controlled Trial
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.
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.
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.
We found this trial at
1
site
800 Washington St
Boston, Massachusetts 02111
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Sunita Pereira, MD
Phone: 617-636-4197
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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