Supporting mothers of preterm infants: A randomized controlled trial
Last registered on August 09, 2017

Pre-Trial

Trial Information
General Information
Title
Supporting mothers of preterm infants: A randomized controlled trial
RCT ID
AEARCTR-0001375
Initial registration date
September 16, 2016
Last updated
August 09, 2017 12:02 PM EDT
Location(s)

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Primary Investigator
Affiliation
Harvard School of Public Health
Other Primary Investigator(s)
PI Affiliation
Harvard T.H. Chan School of Public Health
PI Affiliation
Tufts Medical Center
Additional Trial Information
Status
On going
Start date
2017-01-12
End date
2018-04-27
Secondary IDs
Abstract
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 financial support to low-income mothers of babies born preterm in a hospital in Boston, MA to help them provide STSC. Half of the participants will be randomized to receive an additional support intervention while their infant is in the NICU. We will examine how this intervention impacts mothers' health behavior while their child is in the NICU and the impact on key outcomes 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.
External Link(s)
Registration Citation
Citation
Fink, Gunther, Margaret McConnell and Sunita Pereira. 2017. "Supporting mothers of preterm infants: A randomized controlled trial." AEA RCT Registry. August 09. https://www.socialscienceregistry.org/trials/1375/history/20335
Experimental Details
Interventions
Intervention(s)
Study enrollment will be restricted to children born between 30 and 0/7th weeks and 36 completed weeks of gestation without any major complications requiring additional or special medical care for mother and child (this includes congenital, surgical, or cardiac anomalies in the baby). All participants will be provided with standard information about the benefits of STSC and breastfeeding and will be encouraged to come into the NICU every day for at least 1 hour of STSC. To facilitate increased let down of breast milk, all participants will be provided a hospital grade breast pump free of charge (a 300-dollar rental cost) during the stay of their babies in the NICU and assistance will be provided to the mothers in procuring a Medicaid covered breast pump to keep when the baby leaves the NICU. The hospital grade breast pump will be provided to her as soon as she enrolls into the study and will remain with her until her baby is discharged. We will also provide every study participant with a small gift at the end of the trial to thank them for the time spent with the survey team at the end of the end line interview.

Subjects randomized to the intervention arm will be contacted to be informed that they are eligible to receive a weekly financial transfer of $200 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. The financial transfer will not exceed a total of $600 as at the range of gestations being studied, average length of stay is less than 3 weeks in the NICU for the infant (the mothers of infants staying longer will not be provided with more than $600 regardless of duration of NICU stay). The participants selected for the intervention arm will be asked not to discuss the payment with any other study participants (such as the members of any other families they may see at the NICU) or other health care staff at the NICU.
Intervention Start Date
2017-01-12
Intervention End Date
2018-01-12
Outcomes
Outcomes (end points)
Primary outcome measure: 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) Secondary outcome measures: Any breastfeeding at 3 months (fraction of mothers still breastfeeding - does not need to be exclusive - their infants at 3 months), Breastfeeding initiation (fraction of enrolled mothers who ever begin breastfeeding), Duration of NICU stay, Change in weight-for-age z-score (between birth and after 3 months), Exclusive breastfeeding duration (mean weeks of exclusive breastfeeding duration among enrolled mothers), Change in head circumference (difference between head circumference z-score at birth and at 3 months post-discharge), Infant development (measured by motor, communication, and socioemotional scores), Mental/emotional wellbeing of mother (Mental/emotional wellbeing score of enrolled mothers based on SF-36 and Edinburgh Scale Attachment score between enrolled mothers and their preterm infant based on Postpartum Bonding Questionnaire), Mother-infant attachment (Attachment score between enrolled mothers and their preterm infant based on Postpartum Bonding Questionnaire), Readmissions (Fraction of infants who were readmitted to the hospital post-discharge and the mean duration of their stay), Cost and cost-effectiveness (Total cost of infant's care, including both hospital and out-of-pocket spending)
Outcomes (explanation)
Experimental Design
Experimental Design
This is a randomized controlled trial, clustered at the level of the participant (mother). There are two arms, to which participants will be randomized equally. The inclusion and exclusion criteria are as follows.
Inclusion criteria: subjects will be approached for recruitment if they are
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: subjects will be excluded from the study if they
1. are under the age of 18 years
2. are not currently covered by Medicaid
3. are unable to speak or understand English or Spanish
4. are not residents of the state of Massachusetts
5. have any of the following complications: HIV infection, active TB, 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.
Experimental Design Details
Not available
Randomization Method
Randomization done in office by a computer by research team. Nurses provided care will be blinded to treatment arm.
Randomization Unit
Individual
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
The study is clustered at the level of the mother (the individual participant). There will be 68 mothers enrolled, and outcomes will be measured among both mothers and their infants (with the potential for some births to contain multiples).
Sample size: planned number of observations
68
Sample size (or number of clusters) by treatment arms
34 control participants, 34 treatment participants (outcomes will be measured among the participants and their infants)
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Tufts Medical Center and Tufts University Health Sciences Institutional Review Board
IRB Approval Date
2016-05-25
IRB Approval Number
IRB#12046, 00000577