The efficacy of swaddling in infants who cry excessively: a randomised controlled trial
| ISRCTN | ISRCTN18400679 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18400679 |
| Protocol serial number | ZonMW: 2100.0061; NTR279 |
| Sponsor | Sponsor not defined (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, single-blind, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 12 Weeks |
| Sex | All |
| Target sample size at registration | 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
3508 AN
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
