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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01131156
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : May 14, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Smoking Behavioral: Smoking Relapse Prevention

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit
Study Start Date : May 2009
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. 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

  2. Duration of breastfeeding [ Time Frame: 8 weeks postpartum ]
    Duration of breastfeeding during the first 8 weeks postpartum following the birth of newborn infant.


Eligibility Criteria

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Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

Responsible Party: Raylene Phillips, MD, Medical Doctor, Loma Linda University
ClinicalTrials.gov Identifier: NCT01131156     History of Changes
Other Study ID Numbers: 58108
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014

Keywords provided by Raylene Phillips, MD, Loma Linda University:
postpartum
smoking
relapse
breastfeeding

Additional relevant MeSH terms:
Recurrence
Disease Attributes
Pathologic Processes