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Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit (NICU)

This study has been completed.
Sponsor:
Collaborators:
American Academy of Pediatrics
Flight Attendant Medical Research Institute
March of Dimes
Information provided by (Responsible Party):
Raylene Phillips, MD, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01131156
First received: May 25, 2010
Last updated: May 12, 2014
Last verified: May 2014

May 25, 2010
May 12, 2014
May 2009
June 2010   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01131156 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit (NICU)
Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Smoking
Behavioral: Smoking Relapse Prevention
Mothers were given information about normal newborn behaviors using books, DVDs, and handouts that were appropriate for their baby's gestational age and were also encouraged to participate in frequent skin-to-skin holding of their babies.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mothers:

    • Who had quit smoking during pregnancy or within one year prior to pregnancy
    • Who had newborns < 1 week old at the time of admission to our NICU.

Exclusion Criteria:

  • Mothers:

    • Who were smokers at the time of delivery
    • Whose infant's length of stay < one week
    • Who were not available (jail, adoption)
    • Who had a history of drug use
    • Who did not speak English
Both
up to 1 Week
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01131156
58108
Yes
Raylene Phillips, MD, Loma Linda University
Loma Linda University
  • American Academy of Pediatrics
  • Flight Attendant Medical Research Institute
  • March of Dimes
Principal Investigator: T. Allen Merritt, MD, MHA Loma Linda University, School of Medicine
Loma Linda University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP