Infant respiratory function/thermoregulation/weight and height gain/sleep, fussing and restlessness Respiratory Acute upper respiratory infections of multiple and unspecified sites
Conditions
Interventions
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 swadd
Sponsors
Individual Sponsor (UK)
Eligibility
Sex/Gender
Female
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
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Mongolia
Outcome results
None listed