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
  Purpose

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.


Condition Intervention
Smoking
Behavioral: Smoking Relapse Prevention

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • 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.


Enrollment: 54
Study Start Date: May 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 1 Week
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01131156

Locations
United States, California
Loma Linda University Children's Hospital
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
American Academy of Pediatrics
Flight Attendant Medical Research Institute
March of Dimes
Investigators
Principal Investigator: T. Allen Merritt, MD, MHA Loma Linda University, School of Medicine
  More Information

No publications provided

Responsible Party: Raylene Phillips, MD, Medical Doctor, Loma Linda University
ClinicalTrials.gov Identifier: NCT01131156     History of Changes
Other Study ID Numbers: 58108
Study First Received: May 25, 2010
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
postpartum
smoking
relapse
breastfeeding

ClinicalTrials.gov processed this record on September 15, 2014