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Supporting mothers of preterm infants: A randomized controlled trial

Last registered on September 16, 2016
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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

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
September 16, 2016, 9:54 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country
United States of America
Region
Boston, MA

Primary Investigator

Name
Margaret McConnell
Affiliation
Harvard School of Public Health
Contact Primary Investigator

Other Primary Investigator(s)

PI Name
Gunther Fink
PI Affiliation
Harvard T.H. Chan School of Public Health
Contact Investigator
PI Name
Sunita Pereira
PI Affiliation
Tufts Medical Center
Contact Investigator

Additional Trial Information

Status
In development
Start date
2016-11-01
End date
2018-02-01
Keywords
Health
Additional Keywords
JEL code(s)
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. 2016. "Supporting mothers of preterm infants: A randomized controlled trial." AEA RCT Registry. September 16. https://doi.org/10.1257/rct.1375-1.0
Former Citation
Fink, Gunther, Margaret McConnell and Sunita Pereira. 2016. "Supporting mothers of preterm infants: A randomized controlled trial." AEA RCT Registry. September 16. https://www.socialscienceregistry.org/trials/1375/history/10643
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
Study enrollment will be restricted to children born between 32 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.
Intervention Start Date
2016-11-01
Intervention End Date
2017-11-01

Primary Outcomes

Primary Outcomes (end points)
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)
Breastfeeding initiation: Fraction of enrolled mothers who ever begin breastfeeding
Breastfeeding duration: Mean weeks of breastfeeding (any – does not need to be exclusive) duration among enrolled mothers
Duration of NICU stay: Number of days infants stay in the NICU before discharge
Change in weight-for-age: Difference between birthweight percentile and weight-for-(corrected)-age percentile of infant at 3 months post-discharge
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Subjects randomized to receive cash transfer 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 be capped at a total of $600. 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.
Experimental Design Details
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)
Supporting Documents and Materials
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
00000577
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials