Baby Business: the first few months of life
Not Applicable
Completed
- Conditions
- Early infant sleep and cry problemsSigns and Symptoms
- Registration Number
- ISRCTN63834603
- Lead Sponsor
- Murdoch Childrens Research Institute (MCRI) (Australia)
- Brief Summary
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22309617 2. 2014 results in https://pubmed.ncbi.nlm.nih.gov/24394682/ (added 26/02/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 781
Inclusion Criteria
Families of newborn infants in the local government areas of Yarra, Brimbank and Wyndham (all based around Melbourne, Australia).
Exclusion Criteria
1. Parents of infants who were born at less than 32 weeks gestation
2. Parents of infants with a severe health problem
3. Parents who cannot read, write or speak English well enough to complete questionnaires, a telephone call and a group session
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Infant sleep and crying problems as reported by the parents and as recorded in a 72 hour baby diary.
- Secondary Outcome Measures
Name Time Method <br> 1. Postnatal depression (Edinburgh Postnatal Depression Scale [EPDS])<br> 2. Costs associated with seeking external help for infant sleep and cry problems and parental depression<br><br> Both will be measured when the babies reach 4 and then 6 months of age.<br>