The efficacy of swaddling in infants who cry excessively: a randomised controlled trial
| ISRCTN | ISRCTN18400679 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18400679 |
| Secondary identifying numbers | ZonMW: 2100.0061; NTR279 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 04/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr B E van Sleuwen
Scientific
Scientific
University Medical Center Utrecht
Wilhelmina Children's Hospital
Lundlaan 6
P.O. Box 85090
Utrecht
3508 AN
Netherlands
| Phone | +31 (0)30 250 4111 |
|---|---|
| b.e.vansleuwen@umcutrecht.nl |
Study information
| Study design | Multicentre, randomised, single-blind, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study objectives | 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(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2001 |
| Completion date | 01/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 12 Weeks |
| Sex | Both |
| Target number of participants | 398 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/02/2001 |
| Date of final enrolment | 01/08/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht
Utrecht
3508 AN
Netherlands
3508 AN
Netherlands
Sponsor information
Sponsor not defined (The Netherlands)
Not defined
Not defined
-
-
-
Netherlands
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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 |
