Utilization of a biliblanket to decrease the need for overhead phototherapy and admission to a special care baby unit - a randomised control trial (BiB trial)
Neonatal physiological jaundice
Randomisation will occur on receipt of informed consent. A computer-generated random number list will be used, prepared by an investigator with no clinical involvement in the trial. Sequence generation will be stratified by gestational age – under 37 weeks and over 37 weeks. Once generated the randomisation lists will be sealed in opaque envelopes. Once the patient is consented to enter the trial, the investigator will open the next sequential opaque envelope in the correct strata and provide the allocated interventions. In the case of multiple births, each infant will be individually randomised. Blinding of parents or research staff will not be possible due to the nature of the intervention. The intervention group will be treated with a biliblanket system on the postnatal ward. The control group will have standard care (no biliblanket). Both groups will have serum bilirubin levels monitored every 12 hours until they require overheard phototherapy treatment or they reach a safe level for their age and gestation. After receipt of a serum bilirubin level near the treatment line (less than 35 umol/l below treatment line for age taken) when compared with age on an appropriate treatment nomogram, the parents or guardians of the infant will be approached for informed consent by a member of the research team or a neonatal doctor.
1. Infant greater than 24 hours of age on post natal ward 2. Greater than 35 weeks gestation 3. Suspected physiological jaundice 4. Serum bilirubin less than 35 umol/l under the phototherapy line
1. Jaundice under 24 hours 2. Infants admitted to the neonatal unit for any reason 3. Infant less than 35 weeks gestation 4. Known Direct Coombs Test (DCT) positive jaundice at time of recruitment