A randomised controlled trial to compare alternative strategies for preventing infant crying and sleeping problems in the first 3 months of life

ISRCTN	ISRCTN61156660
DOI	https://doi.org/10.1186/ISRCTN61156660
Secondary identifying numbers	MCH 09-06

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 19/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jennifer Sleep
Scientific

Centre for Evidence-based Practice
Thames Valley University
Royal Berkshire Hospital
Reading
RG1 5AN
United Kingdom

Phone	+44 (0)1225 336527
Email	Jennysleep@hotmail.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Other
Scientific title
Study objectives	The primary aim was to measure the effects of a behavioural intervention on infant crying and sleeping behaviour in the first three months compared with a potentially low cost educational intervention and existing service provision within the NHS. An economic evaluation was designed to estimate the annual cost to the NHS of infant crying and sleeping problems in the first 12 weeks of life and to assess the cost effectiveness of interventions aimed to prevent infant crying and sleeping problems relative to the usual services.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Infant crying and sleeping problems
Intervention	A randomised controlled trial in which mother and baby pairs were allocated to one of 3 policies. 1. The behavioural intervention encouraged mothers to accentuate day/night differences so that babies learned to regulate sleep and waking behaviour according to environmental cues. This involved introducing a late evening focal feed, trying not to rock, hold or feed babies to sleep, to settle them in a darkened environment and to minimise interaction during the night. 2. The educational intervention comprised an information booklet which incorporated current best practice related to managing/preventing infant crying and promoting good sleeping patterns. This was prepared in collaboration with Health Visitors. Mothers were also provided with a dedicated telephone help-line organised by a voluntary support group CRYSIS. 3. The control group mothers and babies received the standard community services offered by Health Visitors and GPs as did all the trial participants. Randomisation was delayed until the mother was at home in order to allow time for recovery following childbirth and to minimise the risk of mergence between the policies. Throughout the first 12 weeks, contact with Health Visitors and/or GPs regarding infants' crying/sleeping problems were recorded; in addition, the babies' weight gain, health and use of medications were monitored. At 9 months mothers' reported whether or not their babies had a regular bedtime routine and whether they had sought professional advice because of their babies' crying or sleeping problems.
Intervention type	Other
Primary outcome measure	1. Number of 'interruption-free nights' per week 2. Measures of babies' crying. 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	Not provided at time of registration
Overall study start date	01/09/1996
Completion date	01/09/1997

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	610 (behavioural programme [n = 205], educational intervention [n = 202], or control [n = 203]) (Added 19/11/09)
Key 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
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/09/1996
Date of final enrolment	01/09/1997

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Centre for Evidence-based Practice

Reading
RG1 5AN
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Not defined

NHS Mother and Child Health National Research and Development Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results on cost analysis	01/01/2001		Yes	No
Results article	results	01/06/2001		Yes	No