A randomised controlled trial to compare alternative strategies for preventing infant crying and sleeping problems in the first 3 months of life
Completed
- Conditions
- Infant crying and sleeping problemsNeonatal Diseases
- Registration Number
- ISRCTN61156660
- Lead Sponsor
- Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 610
Inclusion Criteria
Mothers were eligible for inclusion if:
1. they gave birth to their babies at the Royal Berkshire Hospital, Reading
2. they lived in West Berkshire or South Oxfordshire
3. were English speaking and literate
4. owned a telephone
5. their babies were >37 weeks gestation and had not been admitted to Special Care Baby Unit or shown evidence of congenital abnormality
Exclusion Criteria
Does not match inclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Number of 'interruption-free nights' per week <br>2. Measures of babies' crying. <br>An 'interruption-free night' was defined as a night in which parents reported their baby to remain asleep for 5 hours or more between 10pm and 6am.
- Secondary Outcome Measures
Name Time Method ot provided at time of registration