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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN61156660
Enrollment
610
Registered
2004-01-23
Start date
1996-09-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant crying and sleeping problems Neonatal Diseases

Interventions

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
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

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Does not match inclusion criteria

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026