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Clinical Trial Summary

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.


Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01131156
Study type Interventional
Source Loma Linda University
Contact
Status Completed
Phase N/A
Start date May 2009
Completion date June 2010

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