Back to History

Fields Changed

Registration

Field Before After
Trial Start Date December 12, 2016 December 23, 2016
Last Published December 07, 2016 02:00 PM December 21, 2016 12:05 PM
Intervention Start Date December 12, 2016 December 23, 2016
Primary Outcomes (End Points) 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) 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)
Back to top