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Registration

Field Before After
Trial End Date February 01, 2018 April 27, 2018
Last Published January 12, 2017 01:09 PM August 09, 2017 12:02 PM
Experimental Design (Public) 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. 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.
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Irbs

Field Before After
IRB Approval Number 00000577 IRB#12046, 00000577
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