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

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN41832812
• Date of registration: 20/11/2009
• Prospective Registration: No
• Primary sponsor: Individual Sponsor (UK)
• Public title: Investigation of the effect of swaddling upon psychomotor and mental development in children at 13 and 36 months of age in Mongolia
• Scientific title: 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
• Date of first enrolment: 10/09/2002
• Target sample size: 1250
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN41832812
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)

Countries of recruitment

Mongolia

Contacts

• Name: Semira Manaseki-Holland

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Infant motor/psychosocial development
Respiratory
Unspecified acute lower respiratory infection

Intervention(s)

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 until 12 months of age; 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 background, morbidity and mother related data were collected, and children tested for development achievements..

Swaddling group:
The babies randomised into the swaddling group were to be swaddled in the common traditional Mongolian method as much as they felt comfortable at least until 7 months follow-up. Traditional swaddling in Mongolia was as follows:
Swaddling was a tightly wrapping (2 adult fingers pass under the cloth) of a baby in several layers of cloth, covered by one warmer blanket from head to toe in a straight position after birth for about six months. Two or three ropes were used across a baby's body for binding to avoid unwrapping. For the first three months baby was swaddled most of the day and night with changes of the soiled cloth made every three or eight hours. After this age, practice varies with reducing hours of swaddling, but most infants were swaddled during sleep at least until 7 - 12 months. Duration and tightness of wrapping decreased with age. Furthermore as the baby grew, swaddling clothes for indoor may not have covered the head and would enclose the legs, trunk and arms up to the infant's necks, while after 6 months, in some occasions it only enclosed up to the waist. In the swaddling group, there was expected to be some variation in the swaddling period after 2 to 3 months, but it was usually expected to be more than 17 in 24 hours for those living in colder dwellings. Since the non-swaddling clothes had to be provided with alternatives to the readily available swaddling clothes and blankets, the swaddled group were given

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

063468

Source(s) of Monetary Support

The Wellcome Trust (UK) (grant ref: 063468), United Nations Children's Fund (UNICEF) Mongolia office and Canada Fund (Mongolia) (ref: MON2003/2004.02)