Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit (NICU)
The investigators hypothesized that an enriched focus on mother-infant bonding during a newborn's hospitalization in the Neonatal Intensive Care Unit would reduced the rate maternal postpartum smoking relapse and would prolong the duration of breastfeeding in mothers who had quit smoking during or just prior to pregnancy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit|
- Duration of smoke-free status [ Time Frame: 8 weeks postpartum ] [ Designated as safety issue: No ]Duration of maternal smoke-free status during the first 8 weeks postpartum following delivery of newborn infant
- Duration of breastfeeding [ Time Frame: 8 weeks postpartum ] [ Designated as safety issue: No ]Duration of breastfeeding during the first 8 weeks postpartum following the birth of newborn infant.
|Study Start Date:||May 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Behavioral: Smoking Relapse Prevention
Mothers of newborns admitted to the Neonatal Intensive Care Unit (NICU), who had quit smoking during or just prior to pregnancy where randomized to either the Standard of Care or Smoking Relapse Prevention group. Mothers in both groups were encouraged to remain smoke free following the birth of their babies and were given routine lactation support for breastfeeding during their babies' hospitalization in the NICU. Mothers in the Smoking Relapse Prevention group were also given the study intervention, which was enhanced support for maternal-infant bonding by providing information about their newborn's behaviors using books, DVDs, and handouts that were appropriate for their baby's gestational age and by encouraging frequent skin-to-skin holding.
Primary outcomes included duration of smoke-free status and duration of breastfeeding.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131156
|United States, California|
|Loma Linda University Children's Hospital|
|Loma Linda, California, United States, 92354|
|Principal Investigator:||T. Allen Merritt, MD, MHA||Loma Linda University, School of Medicine|