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
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