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

Investigation of the effect of swaddling upon psychomotor and mental development in children at 13 and 36 months of age in Mongolia: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN41832812
Enrollment
1250
Registered
2009-11-20
Start date
2002-09-10
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Infant motor/psychosocial development Respiratory Unspecified acute lower respiratory infection

Interventions

All infants were recruited at birth and randomised to swaddling versus non-swaddling groups. Babies were then followed up intensely for 7 months (see phase I for more details) and then not seen again
they had another follow-up contact at 13 months of age (or as soon after this time when they came for testing). There was also another visit at 3.5 years of each to each child and family when backgrou

Sponsors

Individual Sponsor (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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: 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 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) 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

MeasureTime frame
Length 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.

Countries

Mongolia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026