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Baby Business: the first few months of life
ISRCTN ISRCTN63834603
DOI 10.1186/ISRCTN63834603
ClinicalTrials.gov identifier
EudraCT number
Public title Baby Business: the first few months of life
Scientific title The impact of a brief universal parenting program to prevent early infant sleep and cry problems and associated parental depression: a randomised controlled trial
Acronym N/A
Serial number at source 28130B
Study hypothesis It is hypothesised that in comparison to the control group, the Baby Business intervention will result in fewer infant crying and sleeping problems, and secondarily, will result in reduced post-natal depression.

It is also predicted that this in turn, will reduce health service costs related to management of infant crying and sleep problems.
Lay summary Not provided at time of registration
Ethics approval 1. Royal Children's Hospital Human Research Ethics Committee approved on the 5th January 2009 (ref: 28130B)
2. Department of Education and Early Childhood Development Early Childhood Research Committee approved on the 10th December 2009
Study design Randomised controlled trial
Countries of recruitment Australia
Disease/condition/study domain Early infant sleep and cry problems
Participants - inclusion criteria Families of newborn infants in the local government areas of Yarra, Brimbank and Wyndham (all based around Melbourne, Australia).
Participants - 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
Anticipated start date 15/02/2010
Anticipated end date 15/06/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 750
Interventions Maternal child health nurses will approach all parents at the first postnatal home visit (which usually takes place at infant age 1 - 2 weeks) and invite them to participate. All participating primary care-givers will complete a baseline questionnaire including socio-demographic data, infant details (birth weight, birth order, gender, date of birth), feeding method (breast, formula, combination of breast/formula) and whether the infantís sleep or crying is a problem. Both parents will be encouraged to take part in the study.

Baby Business Intervention:
Parents in the intervention group will be offered a brief parenting intervention in addition to their usual post-natal care. The intervention will consist of:
1. A parenting booklet and DVD
2. A telephone consultation when the infant is 3 - 7 weeks old, followed by
3. A group parenting session at a local maternal child health centre for all parents when their infant is 8 - 12 weeks old

The intervention will focus on normal infant sleep and crying and ways to encourage infants to self-soothe. It will aim to address all concerns raised by parents. Appropriate referrals to other services will be organised if necessary. The intervention will be performed by a member of the research team who is a health professional with expertise in managing maternal and infant health issues in the first few months of life.

Control Group:
Parents in the control group will receive usual post-natal health care.

All parents will complete follow up questionnaires addressing infant sleep and cry problems and parental wellbeing when their infants turn 4 and 6 months of age.
Primary outcome measure(s) Infant sleep and crying problems as reported by the parents and as recorded in a 72 hour baby diary.
Secondary outcome measure(s) 1. Postnatal depression (Edinburgh Postnatal Depression Scale [EPDS])
2. Costs associated with seeking external help for infant sleep and cry problems and parental depression

Both will be measured when the babies reach 4 and then 6 months of age.
Sources of funding 1. Department of Education and Early Childhood Development (Australia)
2. The Scobie and Claire MacKinnon Trust (Australia)
Trial website
Publications 1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22309617
Contact name Dr  Harriet  Hiscock
  Address Royal Children's Hospital
Centre for Community Child Health
Flemington Road
  City/town Parkville
  Zip/Postcode 3052
  Country Australia
  Tel +61 (0)3 9345 6910
  Fax +61 (0)3 9345 5900
  Email harriet.hiscock@rch.org.au
Sponsor Murdoch Childrens Research Institute (MCRI) (Australia)
  Address Flemington Road
  City/town Parkville
  Zip/Postcode 3052
  Country Australia
  Tel +61 (0)3 8341 6200
  Fax +61 (0)3 9348 1391
  Email mcri@mcri.edu.au
  Sponsor website: http://www.mcri.edu.au
Date applied 17/05/2010
Last edited 30/07/2012
Date ISRCTN assigned 14/07/2010
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