Investigation of the effect of swaddling upon psychomotor and mental development in children at 13 and 36 months of age in Mongolia

Completed

Conditions: Infant motor/psychosocial development
Respiratory
Unspecified acute lower respiratory infection

Registration Number: ISRCTN41832812

Lead Sponsor: Individual Sponsor (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 1250

Inclusion Criteria

1. All babies born in the only four maternity hospitals of Ulaanbaatar (greater than 95% births were in these facilities)
2. Within 48 hours of birth if resident of Ulaanbaatar
3. Mother was well enough to discuss consent

Exclusion Criteria

1. Refusal to consent
2. Birth weight less than 2500 g
3. Less than 36 weeks gestation
4. Obvious congenital abnormalities (with clear medical consequences)
5. Need for infant intensive care treatment
6. Residence in ?very warm? apartments (defined by the mother) since a pilot study indicated such families considered the home to be too hot for the baby to be wrapped

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BSID-II, an internationally acclaimed test of mental and psychomotor development in early childhood, measured at 12 - 15 months of age and again at 3.5 years:<br>1. BSID-II mental scale: evaluates children?s sensory/perceptual acuities, discriminations, and response; acquisition of object constancy; memory learning and problem solving; vocalization and beginning of verbal communication; basis of abstract thinking; habituation; mental mapping; complex language; and mathematical concept formation<br>2. BSID-II psychomotor scale: evaluates the degree of body control; large muscle coordination; fine manipulatory skills of the hands and fingers; dynamic movement; postural imitation; and stereognosis (ability to recognize objects by sense of touch)<br><br>Test scores are reported as scaled scores based on the infant?s age, with a normed mean of 100 (SD = 15 points). Both scales have high correlation coefficients (0/83 and 0/77 respectively) for test-retest reliability.

Secondary Outcome Measures

Name	Time	Method
ength or height, head circumference, or Mid Upper Arm Circumference (MUAC) in cm (to the nearest 0.5cm); and weight in grams. Measured at 12 - 15 months of age.