The efficacy of swaddling in infants who cry excessively; a randomized controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27533

Enrollment

398

Registered

2005-09-08

Start date

2001-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Excessive crying infants.

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 t

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactB.E. Sleuwen, van

University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital, P.O. Box 85090

b.e.vansleuwen@umcutrecht.nl+31 (0)30 2504111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)