Condition category
Signs and Symptoms
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
04/11/2008
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

Dr B E van Sleuwen

ORCID ID

Contact details

University Medical Center Utrecht
Wilhelmina Children's Hospital
Lundlaan 6
P.O. Box 85090
Utrecht
3508 AN
Netherlands
+31 (0)30 250 4111
b.e.vansleuwen@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMW: 2100.0061; NTR279

Study information

Scientific title

Acronym

Study hypothesis

We compared two interventions: behavioural modification of baby care through regularity and stimuli reduction, which has been shown effective in one controlled study, and the same approach supported with swaddling during all sleeping periods. Our conclusion will be based on if there is any added effect of swaddling.

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre, randomised, single-blind, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Excessive crying, infants

Intervention

A standardised approach which consists of offering regularity and stimulus reduction was compared with an experimental group which received the same approach, supplemented with swaddling. Specially trained health care nurses guided the parent-infant couples for a period of three months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

During the first days of intervention the behavioural approach caused an increase in crying. After several days this effect disappeared and crying decreased rapidly in all subgroups. Swaddling on the other hand, showed an immediate positive effect on crying. After 7 days both groups did not differ until the end of intervention. Crying decreased in both groups after the first intervention week with 42%. Therefore, swaddling has no added benefit in reducing crying in the total group. However, when stratified by age different strategies had significantly different effect. Young infants (aged 1 - 7 weeks at randomisation) benefit significantly more from swaddling as shown by a larger decrease of crying and larger increase in sleep time. Older infants (8 - 13 weeks at randomisation) showed a significantly greater decrease in crying when not swaddled, but only offered stimuli reduction and regulation in baby care.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/02/2001

Overall trial end date

01/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Clinically healthy infants in the age of 0 - 12 weeks and 6 days who cry excessively, who have no (increased) risk for developmental hip dysplasia.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

398

Participant exclusion criteria

1. Clinically non-healthy infants or infants with a physical explanation for the excessive crying
2. Infants older than 12 weeks and 6 days
3. Infants born before 32 weeks of gestational age
4. Infants with an increased risk for developmental hip dysplasia

Recruitment start date

01/02/2001

Recruitment end date

01/08/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht
Utrecht
3508 AN
Netherlands

Sponsor information

Organisation

Sponsor not defined (The Netherlands)

Sponsor details

-
-
-
Netherlands

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

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

Publication citations

Additional files

Editorial Notes