Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit (NICU)
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|ClinicalTrials.gov Identifier: NCT01131156|
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : May 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Behavioral: Smoking Relapse Prevention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
Behavioral: Smoking Relapse Prevention
- Duration of smoke-free status [ Time Frame: 8 weeks postpartum ]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 ]Duration of breastfeeding during the first 8 weeks postpartum following the birth of newborn infant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|