The Effects of Second-hand Smoke in New BornsNCT01995409
Mothers Learning About Second-hand Smoke - MLASS Study
A study testing No smoking material provided in households with newborn infants in people with The Effects of Second-hand Smoke in New Borns, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Exposure to second-hand smoke during pregnancy and early infancy leads to low birth weight and childhood illnesses. 50% of all newborns in the UK are exposed to tobacco smoke due to maternal smoking or contact with second-hand smoke. Read more about this study
- Who is it for?
- Ages 17 to 40 years
- Conditions the study is for
- The Effects of Second-hand Smoke in New Borns
- What is being tested?
- No smoking material provided in households with newborn infants
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Sep 2014
- 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 17 to 40 years
- All sexes
- Child, Adult
Who may be able to join
- Pregnant
- Smokers; or, non-smokers who live in a household with an adult who smokes or in a household with regular visitors to the home who smoke
- Aged 17-40 years of age
- Living in neighbourhoods in Leeds that are among the 40% most deprived in England Inclusion criteria for newborns
- Born to a woman already recruited into the study
Who cannot join
- Not pregnant or have a miscarriage during pregnancy
- Non-smokers who do not live in a household with an adult who smokes or in a household with regular visitors to the home who smoke
- Having serious health complications during pregnancy or after childbirth
- Known or suspected to be in an abusive relationship Exclusion criteria for newborns
- Having serious health complications after birth or requiring hospitalisation
- Living in neighbourhoods in Leeds that are not among the 40% most deprived in England . being permanently looked after in home separate from mother's
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Leeds Teaching Hospital NHS Trust
Leeds, LS9 7TF
Julie Scarfe, RN, RM, BSc, MA.
About this study
Exposure to second-hand smoke during pregnancy and early infancy leads to low birth weight and childhood illnesses. 50% of all newborns in the UK are exposed to tobacco smoke due to maternal smoking or contact with second-hand smoke.
The purpose of this study is to test the feasibility of delivering and evaluating the effectiveness of a Smoke Free Homes (SFH) health education intervention with pregnant women and mothers with newborns to reduce unborn and newborn babies exposure to second-hand smoke. The intervention will be delivered through routine antenatal and postnatal healthcare settings provided by midwifery and health visiting services.
Read more
The intervention consists of educational materials to be given to the woman and a conversation held between the woman and midwife/health visitor about protecting the baby from second-hand smoke. The development of the intervention has been informed by the views of health professionals and service users, incorporates behaviour change theory and has drawn on other SFH materials developed for other settings. Different parts of the intervention will be delivered at different points along the antenatal and postnatal care pathway. 200 pregnant women and their newborns will be recruited.
We will measure salivary cotinine levels to assess the level of exposure to SHS in women and urinary cotinine levels in newborns. We plan to conduct a before-and-after study of the delivery of the intervention to test the feasibility of delivering, and methods to evaluate the effectiveness of the intervention.
Feasibility study outputs:
- A standardised, acceptable, feasible and appropriate health education intervention to protect unborn and newborn babies exposure to second-hand smoke at home, capable of being integrated into routine midwifery and health visiting practice
- A trial protocol to evaluate the effectiveness of the intervention on unborn and newborn babies' exposure to secondhand smoke.
- Being tested
- No smoking material provided in households with newborn infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No smoking material provided in households with newborn infantsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cotinine levels in women who do not smoke during pregnancy, and urine cotinine levels in newborns.
We will assess the level of smoking restrictions at home through a Household Survey (questionnaire) completed by the women. The survey is divided into two parts. Part One asks for demographic information and this information will only be collected once, at the start of the study. Part Two asks about smoking behaviour and is based on two questions; (a) Do people in the house smoke in front of pregnant mothers and children? (b) Where do people smoke? Participants will be asked to complete Part B at different points throughout their involvement in the study so that the impact of the delivery of different stages of the intervention can be assessed.
Responses to question (a) will be assessed as a binary outcome. However, responses to question (b) will be grouped into one of three categories. Smoking takes place; (i) in any part of the house; (ii) in one room only; (iii) only outside the house. We will add an additional question to assess smoking restrictions on the visitors.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Effects of Second-hand Smoke in New BornsStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995409
- Sponsor's protocol ID
- OG13/10649
- Other IDs
- 12/YH/0257
- Status last verified
- Sep 2014
- First submitted
- 21 Nov 2013
- Last updated
- 25 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mothers Learning About Second-hand Smoke - MLASS Study
- ClinicalTrials.gov ID
- NCT01995409
- Acronym / sponsor ID
- OG13/10649
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- First posted
- 26 Nov 2013 (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.
Exposure to second-hand smoke during pregnancy and early infancy leads to low birth weight and childhood illnesses. 50% of all newborns in the UK are exposed to tobacco smoke due to maternal smoking or contact with second-hand smoke.
The purpose of this study is to test the feasibility of delivering and evaluating the effectiveness of a Smoke Free Homes (SFH) health education intervention with pregnant women and mothers with newborns to reduce unborn and newborn babies exposure to second-hand smoke. The intervention will be delivered through routine antenatal and postnatal healthcare settings provided by midwifery and health visiting services.
The intervention consists of educational materials to be given to the woman and a conversation held between the woman and midwife/health visitor about protecting the baby from second-hand smoke. The development of the intervention has been informed by the views of health professionals and service users, incorporates behaviour change theory and has drawn on other SFH materials developed for other settings. Different parts of the intervention will be delivered at different points along the antenatal and postnatal care pathway. 200 pregnant women and their newborns will be recruited.
We will measure salivary cotinine levels to assess the level of exposure to SHS in women and urinary cotinine levels in newborns. We plan to conduct a before-and-after study of the delivery of the intervention to test the feasibility of delivering, and methods to evaluate the effectiveness of the intervention.
Feasibility study outputs:
- A standardised, acceptable, feasible and appropriate health education intervention to protect unborn and newborn babies exposure to second-hand smoke at home, capable of being integrated into routine midwifery and health visiting practice
- A trial protocol to evaluate the effectiveness of the intervention on unborn and newborn babies' exposure to secondhand smoke.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 17 to 40 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| No smoking material provided in households with newborn infants | Behavioural | – |
Primary outcome
Salivary cotinine levels in women who do not smoke during pregnancy, and urine cotinine levels in newborns.
Time frame: 1 year
We will assess the level of smoking restrictions at home through a Household Survey (questionnaire) completed by the women. The survey is divided into two parts. Part One asks for demographic information and this information will only be collected once, at the start of the study. Part Two asks about smoking behaviour and is based on two questions; (a) Do people in the house smoke in front of pregnant mothers and children? (b) Where do people smoke? Participants will be asked to complete Part B at different points throughout their involvement in the study so that the impact of the delivery of different stages of the intervention can be assessed. Responses to question (a) will be assessed as a binary outcome. However, responses to question (b) will be grouped into one of three categories. Smoking takes place; (i) in any part of the house; (ii) in one room only; (iii) only outside the house. We will add an additional question to assess smoking restrictions on the visitors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No smoking material provided in households with newborn infants in people with The Effects of Second-hand Smoke in New Borns, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 5 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: status not confirmed, as of the sponsor's last update on 25 Sep 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Scarfe, RN, RM, BSc, MA. (0113 2066975, Julie.Scarfe@leedsth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary cotinine levels in women who do not smoke during pregnancy, and urine cotinine levels in newborns. (time frame: 1 year). 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 25 Sep 2014.