SmokingNCT01131156
Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit (NICU)
A study testing Smoking Relapse Prevention in people with Smoking, run by Loma Linda University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages Up to 1 week
- Conditions the study is for
- Smoking
- What is being tested?
- Smoking Relapse Prevention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 week
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Children's Hospital
Loma Linda, California, 92354
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking
- Being tested
- Smoking Relapse Prevention
- Keywords
- postpartum, smoking, relapse, breastfeeding
- Medical subject headings
- Smoking, Recurrence, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Relapse PreventionBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of smoke-free status
Duration of maternal smoke-free status during the first 8 weeks postpartum following delivery of newborn infant
Measured: 8 weeks postpartum
Duration of breastfeeding
Duration of breastfeeding during the first 8 weeks postpartum following the birth of newborn infant.
Measured: 8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startMay 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics, Flight Attendant Medical Research Institute, March of Dimes
- Responsible party
- Principal investigator, Raylene Phillips, MD, Loma Linda University
- Investigators
- T. Allen Merritt, MD, MHA, Principal investigator, Loma Linda University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131156
- Sponsor's protocol ID
- 58108
- Status last verified
- May 2014
- First submitted
- 25 May 2010
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01131156
- Acronym / sponsor ID
- 58108
- Conditions
- Smoking
- Keywords
- postpartum, smoking, relapse, breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics, Flight Attendant Medical Research Institute, March of Dimes
- Study start
- May 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 26 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- Up to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Mothers:
Key exclusion criteria (6 listed)
- Mothers:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking Relapse PreventionMothers 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. | Behavioural | – |
Primary outcome
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
Duration of breastfeeding
Time frame: 8 weeks postpartum
Duration of breastfeeding during the first 8 weeks postpartum following the birth of newborn infant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
T. Allen Merritt, MD, MHA principal investigator
Loma Linda University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Relapse Prevention in people with Smoking, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of smoke-free status (time frame: 8 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.