Trial Outcomes & Findings for Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates (NCT NCT02612727)

Results Overview

For a given evaluable treatment day, the phototherapy treatment was deemed effective if that infant on that day had a decrease in serum bilirubin level or (if \<72hrs old) an rate of increase of less than 0.2 mg/dL/h. Therefore efficacy is reported as a percentage of the evaluable treatment days (i.e. number of effective evaluable treatment days divided by total number of evaluable treatment days).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

174 participants

Primary outcome timeframe

2 to 10 days

Results posted on

2019-07-09

Participant Flow

Participant milestones

Participant milestones
Measure	Filtered-sunlight Phototherapy Infants will receive \>= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film. Filtered-sunlight phototherapy: Infants will receive \>= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film.	Intensive Phototherapy Infants will receive \>= four hours per day of intensive phototherapy for 1 to 10 days. Intensive phototherapy: Infants will receive \>= four hours per day of intensive phototherapy for 1 to 10 days.
Overall Study STARTED	87	87
Overall Study COMPLETED	82	83
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Filtered-sunlight Phototherapy Infants will receive \>= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film. Filtered-sunlight phototherapy: Infants will receive \>= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film.	Intensive Phototherapy Infants will receive \>= four hours per day of intensive phototherapy for 1 to 10 days. Intensive phototherapy: Infants will receive \>= four hours per day of intensive phototherapy for 1 to 10 days.
Overall Study Parent request	4	1
Overall Study Needed treatment incompatible with PT	1	1
Overall Study Direct hyperbilirubinemia	0	2

Baseline Characteristics

Sex information was missing for one infant in each group.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Filtered-sunlight Phototherapy n=87 Participants Infants will receive \>= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film. Filtered-sunlight phototherapy: Infants will receive \>= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film.	Intensive Phototherapy n=87 Participants Infants will receive \>= four hours per day of intensive phototherapy for 1 to 10 days. Intensive phototherapy: Infants will receive \>= four hours per day of intensive phototherapy for 1 to 10 days.	Total n=174 Participants Total of all reporting groups
Age, Continuous	47 hours n=87 Participants	59 hours n=87 Participants	57 hours n=174 Participants
Sex: Female, Male Female	34 Participants n=86 Participants • Sex information was missing for one infant in each group.	30 Participants n=86 Participants • Sex information was missing for one infant in each group.	64 Participants n=172 Participants • Sex information was missing for one infant in each group.
Sex: Female, Male Male	52 Participants n=86 Participants • Sex information was missing for one infant in each group.	56 Participants n=86 Participants • Sex information was missing for one infant in each group.	108 Participants n=172 Participants • Sex information was missing for one infant in each group.

PRIMARY outcome

Timeframe: 2 to 10 days

Population: The efficacy analysis used all treatment days where an infant received \>=4h of PT and both bilirubin levels were available. 87 infants received 215 treatment days of FSPT, but only 133 of those days (in 79 infants) were analyzable for efficacy. Similarly, 87 infants received 219 days of IntPT, but only 152 days (in 83 infants) were analyzable.

For a given evaluable treatment day, the phototherapy treatment was deemed effective if that infant on that day had a decrease in serum bilirubin level or (if \<72hrs old) an rate of increase of less than 0.2 mg/dL/h. Therefore efficacy is reported as a percentage of the evaluable treatment days (i.e. number of effective evaluable treatment days divided by total number of evaluable treatment days).

Outcome measures

Outcome measures
Measure	Filtered-sunlight Phototherapy n=133 treatment days Infants will receive \>= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film. Filtered-sunlight phototherapy: Infants will receive \>= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film.	Intensive Phototherapy n=152 treatment days Infants will receive \>= four hours per day of intensive phototherapy for 1 to 10 days. Intensive phototherapy: Infants will receive \>= four hours per day of intensive phototherapy for 1 to 10 days.
Efficacy of Phototherapy	116 treatment days	135 treatment days

PRIMARY outcome

Timeframe: 2 to 10 days

For a given treatment day, the phototherapy treatment was deemed safe if that infant on that day did not have to be withdrawn from treatment due to hypo- or hyperthermia, sunburn or dehydration. Therefore safety is reported as a percentage of the total treatment days (i.e. number of safe treatment days divided by total number of treatment days).

Outcome measures

Outcome measures
Measure	Filtered-sunlight Phototherapy n=215 treatment days Infants will receive \>= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film. Filtered-sunlight phototherapy: Infants will receive \>= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film.	Intensive Phototherapy n=219 treatment days Infants will receive \>= four hours per day of intensive phototherapy for 1 to 10 days. Intensive phototherapy: Infants will receive \>= four hours per day of intensive phototherapy for 1 to 10 days.
Safety of Phototherapy	215 treatment days	219 treatment days

Adverse Events

Filtered-sunlight Phototherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intensive Phototherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tina M. Slusher

Minnesota Medical Research Foundation (now Hennepin Healthcare) and University of Minnesota

Phone: 612-624-4586

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place