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Field
Trial Start Date
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Before
November 01, 2016
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After
December 12, 2016
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Field
Last Published
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Before
September 16, 2016 09:54 AM
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After
December 07, 2016 02:00 PM
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Field
Intervention (Public)
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Before
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.
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After
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.
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Field
Intervention Start Date
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Before
November 01, 2016
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After
December 12, 2016
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Field
Primary Outcomes (End Points)
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Before
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
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After
Primary outcome measures: 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), 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)
Secondary outcome measures: 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)
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Field
Experimental Design (Public)
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Before
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.
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After
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 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: 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.
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