Back to resultsPrevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit (NICU)
Primary Purpose
Smoking
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smoking Relapse Prevention
Sponsored by
About this trial
This is an interventional prevention trial for Smoking focused on measuring postpartum, smoking, relapse, breastfeeding
Eligibility 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
Sites / Locations
- Loma Linda University Children's Hospital
Outcomes
Primary Outcome Measures
Duration of smoke-free status
Duration of maternal smoke-free status during the first 8 weeks postpartum following delivery of newborn infant
Duration of breastfeeding
Duration of breastfeeding during the first 8 weeks postpartum following the birth of newborn infant.
Secondary Outcome Measures
Full Information
NCT ID
NCT01131156
First Posted
May 25, 2010
Last Updated
May 12, 2014
Sponsor
Loma Linda University
Collaborators
American Academy of Pediatrics, Flight Attendant Medical Research Institute, March of Dimes
1. Study Identification
Unique Protocol Identification Number
NCT01131156
Brief Title
Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit (NICU)
Official Title
Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
Collaborators
American Academy of Pediatrics, Flight Attendant Medical Research Institute, March of Dimes
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking
Keywords
postpartum, smoking, relapse, breastfeeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Smoking Relapse Prevention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of smoke-free status
Description
Duration of maternal smoke-free status during the first 8 weeks postpartum following delivery of newborn infant
Time Frame
8 weeks postpartum
Title
Duration of breastfeeding
Description
Duration of breastfeeding during the first 8 weeks postpartum following the birth of newborn infant.
Time Frame
8 weeks postpartum
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Week
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T. Allen Merritt, MD, MHA
Organizational Affiliation
Loma Linda University, School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Children's Hospital
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit (NICU)
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