|- candidate number||1472|
|- NTR Number||NTR279|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||8-sep-2005|
|- Secondary IDs||ZonMW registration number 2100.0061 |
|- Public Title||The efficacy of swaddling in infants who cry excessively; a randomized controlled trial.|
|- Scientific Title||The efficacy of swaddling in infants who cry excessively; a randomized controlled trial.|
|- hypothesis||We compared two interventions: behavioral 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.|
|- Healt Condition(s) or Problem(s) studied||Excessive crying|
|- 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.|
|- Exclusion criteria||Clinically non-healthy infants or infants with a physical explanation for the excessive crying, infants older than 12 weeks and 6 days, infants born before 32 weeks of gestational age, infants with a(n) (increased) risk for developmental hip dysplasia.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2001|
|- planned closingdate||1-aug-2004|
|- Target number of participants||398|
|- Interventions||A standardized 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.
|- Primary outcome||During the first days of intervention the behavioral 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 randomization) 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 randomization) showed a significantly greater decrease in crying when not swaddled, but only offered stimuli reduction and regulation in baby care.
|- Secondary outcome||N/A|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MSc. B.E. Sleuwen, van|
|- CONTACT for SCIENTIFIC QUERIES||PhD. P. L'Hoir|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||J Pediatr. 2006 Oct;149(4):512-7.|
|- Brief summary||Excessive crying occurs in 5-15% of Dutch infants. Recent research showed that more than 5% of parents of young infants are driven to seriously dangerous behavior such as shaking by the excessive crying of their infant. |
Many interventions can be launched to reduce crying, but in the Netherlands no unambiguous strategy is used. Swaddling could be an effective method to reduce excessive crying, but it has never been systematically investigated.
One controlled study showed effect of a behavioral intervention consisting of stimuli reduction and regularity in babycare.
We conducted a randomized trial using a standardized approach of regularity and stimulus reduction compared to a group receiving the same, supplemented with swaddling.
|- Main changes (audit trail)|
|- RECORD||8-sep-2005 - 16-jun-2008|