Investigation of the effect of swaddling upon lower respiratory infections, respiratory function, crying and sleep, thermal regulation and growth in infants 0 - 7 months in Mongolia

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN01992617
• Date of registration: 20/11/2009
• Prospective Registration: No
• Primary sponsor: Individual Sponsor (UK)
• Public title: Investigation of the effect of swaddling upon lower respiratory infections, respiratory function, crying and sleep, thermal regulation and growth in infants 0 - 7 months in Mongolia
• Scientific title: Investigation of the effect of swaddling upon lower respiratory infections, respiratory function, crying and sleep, thermal regulation and growth in infants 0 - 7 months in Mongolia: a randomised controlled trial
• Date of first enrolment: 10/09/2002
• Target sample size: 1250
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN01992617
• Study type: Interventional
• Study design: Randomised controlled trial (Quality of life)

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: Female

Health Condition(s) or Problem(s) studied

Infant respiratory function/thermoregulation/weight and height gain/sleep, fussing and restlessness
Respiratory
Acute upper respiratory infections of multiple and unspecified sites

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.

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. 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 a blanket and 3 cotton sheets at the time of recruitment.

Swaddling, a cultural norm, was not a difficult infant care practice to achieve in this study. Swaddled babies would often be placed horizontal on a bed or carried, and not positioned vertically as with some cultures.

Non-swaddling group:
The non-swaddling group were instructed not to swaddle at all. The Mongolian stores did not sell the required size an

Primary Outcome(s)

ALRI/pneumonia, identified by passive surveillance at the hospital and primary care centres. Doctors were re-trained in the relevant WHO?s IMCI diagnostic criteria of ALRI and study protocols. Families were incentivised with free transport and medication to ensure better referral to study doctors in case of illness. Home visits by trained fieldworkers every 3 weeks took history of signs, symptoms and all doctor referrals or admissions and these were correlated with passive surveillance data. Infants with signs of ?severe? to very ?severe? pneumonia (IMCI defined) could be admitted and receive a CXR and pulse oximetry by trained study radiographers (trained by WHO expert using WHO criteria). X-ray films were assessed blind by 2 radiologist experts in WHO, Geneva, using consensus and WHO diagnostic pro-forma at the study end.

Measured throughout the study after recruitment until the end of the study (infants birth till 7 months of age, starting September 2002 until end of June 2003).

Secondary Outcome(s)

1. ALRI/pneumonia defined as in primary outcome measure and compared with age by completed months from birth, measured throughout the study after recruitment until the end of the study
2. Oxygen saturation and respiratory rate per minute (SaO2 and RR), measured at 9 - 10 weeks after birth
3. Sleeping and fussing/crying were defined as the overall 24-hour duration and number of bouts of crying and of sleeping and their particular measurements in night and day.
Two measurements of 2 to 24 hours were taken: Four successive typical days when infants were between 4 - 6 and 12 - 14 weeks of age.
4. Infants? temperatures taken from three different body sites (abdomen, periphery and micro-environment) and compared to room temperature, measured by field workers who made visits according to a fixed, regular schedule.
5. Length or height, head circumference, or Mid Upper Arm Circumference (MUAC) in cm (to the nearest 0.5cm); and weight in grams. Infant weight and length were recorded at birth, and then the mean ages of 3, 16, 22, and 31 weeks after birth. Mid-upper arm circumference (MUAC) and head circumference were measured at 52 weeks after birth.

Secondary ID(s)

063468

Source(s) of Monetary Support

The Wellcome Trust (UK) (grant ref: 063468)