Condition category
Neonatal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
19/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jennifer Sleep

ORCID ID

Contact details

Centre for Evidence-based Practice
Thames Valley University
Royal Berkshire Hospital
Reading
RG1 5AN
United Kingdom
+44 (0)1225 336527
Jennysleep@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCH 09-06

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/1996

Overall trial end date

01/09/1997

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

610 (behavioural programme [n = 205], educational intervention [n = 202], or control [n = 203]) (Added 19/11/09)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/09/1996

Recruitment end date

01/09/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Evidence-based Practice
Reading
RG1 5AN
United Kingdom

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Not defined

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11468047
2. 2001 results on cost analysis in http://www.ncbi.nlm.nih.gov/pubmed/11124777

Publication citations

  1. Results

    St James-Roberts I, Sleep J, Morris S, Owen C, Gillham P, Use of a behavioural programme in the first 3 months to prevent infant crying and sleeping problems., J Paediatr Child Health, 2001, 37, 3, 289-297.

  2. Results on cost analysis

    Morris S, James-Roberts IS, Sleep J, Gillham P, Economic evaluation of strategies for managing crying and sleeping problems., Arch. Dis. Child., 2001, 84, 1, 15-19.

Additional files

Editorial Notes