Light treatment (phototherapy) from multiple directions is significantly better than unidirectional light treatment in this pilot study of term breast-fed infants with jaundice

Multidirectional phototherapy versus phototherapy from below for severe neonatal jaundice: a pilot study in Home phototherapy

Registry ID
ISRCTN88608924
Source registry
ISRCTN
Status
No longer recruiting
Study type
INTERVENTIONAL
Sponsor
Saint Michael's Medical Center
Enrollment
20
Start date
2022-03-20
Completion date
2023-06-27
Last update
2026-08-17

Conditions

Summary

Severe neonatal jaundice

Detailed description

Study patients were comprised of infants referred to a single licensed/accredited home health agency in Rhode Island by their outpatient pediatrician for home phototherapy for neonatal jaundice. All infants were ≥37 weeks gestational age and ≥ 2500 grams at the beginning of the treatment. All infants were discharged from the hospital with no evidence of clinical hyperbilirubinemia; the infants in our study were diagnosed with jaundice in the office of their pediatrician at the first office visit post-hospital discharge. In addition, only exclusively breastfeeding dyads were enrolled. Following referral to the home health agency for phototherapy treatment by the outpatient pediatrician, the study was explained to the parents by the nurses employed at the home health agency. After written informed consent, enrolled infants were randomized at a 1:1 ratio to either high-intensity treatment from below or multidirectional phototherapy. Randomization was based on a computer-generated sequence at the home health-care agency, with device assignment provided to the treating nurse. A nurse visited the home daily, clinically assessed the infant and obtained a blood sample for serum bilirubin measurement. This blood sample was then delivered to a CLIA-certified laboratory for processing. The decision to end phototherapy was made by the child’s pediatrician after receiving a report of the bilirubin value from the visiting nurse. Families were not told which device they were assigned. Because the devices are visually different and have different operating instructions, the clinical care team was not blinded. However, the laboratory personnel processing the serum bilirubin levels were blinded to the type of treatment the infant was receiving (multi vs. unidirectional). Additionally, the outpatient physician responsible for each infant was blinded to the type of treatment the infant was receiving in the home (multi vs. unidirectional therapy). Demographic variables collected include

Interventions

Inclusion criteria

1. Hyper bilirubinemia 2. Breast-fed 3. Term 4. Otherwise well

Exclusion criteria

1. Hospitalized 2. Premature 3. Those are received phototherapy in the hospital prior to discharge 4. Non-breast-fed infants

Locations

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