Trial Outcomes & Findings for Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates (NCT NCT01434810)

Results Overview

For a given treatment day, the phototherapy treatment was deemed safe if that infant on that day did not have to be withdrawn from treatment due to hypo- or hyperthermia, sunburn or dehydration.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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

447 participants

Primary outcome timeframe

Four to ten days

Results posted on

2019-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Filtered Sunlight Phototherapy Window tinting film will be used. Window tinting film for filtered sunlight phototherapy: Six hours per day of filtered sunlight phototherapy for 1 to 10 days.	Conventional Phototherapy Infants will be randomized to conventional phototherapy (new arm) Conventional phototherapy: Conventional phototherapy unit will be used for infants randomized to this arm for 1 to 10 days.
Overall Study STARTED	224	223
Overall Study COMPLETED	201	213
Overall Study NOT COMPLETED	23	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Filtered Sunlight Phototherapy Window tinting film will be used. Window tinting film for filtered sunlight phototherapy: Six hours per day of filtered sunlight phototherapy for 1 to 10 days.	Conventional Phototherapy Infants will be randomized to conventional phototherapy (new arm) Conventional phototherapy: Conventional phototherapy unit will be used for infants randomized to this arm for 1 to 10 days.
Overall Study Did not receive treatment	11	3
Overall Study Missing data/received <5hr phototherapy	12	7

Baseline Characteristics

Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Filtered Sunlight Phototherapy n=224 Participants Window tinting film will be used. Window tinting film for filtered sunlight phototherapy: Six hours per day of filtered sunlight phototherapy for 1 to 10 days.	Conventional Phototherapy n=223 Participants Infants will be randomized to conventional phototherapy (new arm) Conventional phototherapy: Conventional phototherapy unit will be used for infants randomized to this arm for 1 to 10 days.	Total n=447 Participants Total of all reporting groups
Age, Customized Est'd gestational age	38 weeks n=5 Participants	38 weeks n=7 Participants	38 weeks n=5 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	103 Participants n=7 Participants	205 Participants n=5 Participants
Sex: Female, Male Male	122 Participants n=5 Participants	120 Participants n=7 Participants	242 Participants n=5 Participants

PRIMARY outcome

Timeframe: Four to ten days

Population: Safety was assessed for all 593 days on which treatment was received, in all 433 participants who were treated.

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=268 treatment days Window tinting film will be used. Window tinting film for filtered sunlight phototherapy: Six hours per day of filtered sunlight phototherapy for 1 to 10 days.	Conventional Phototherapy n=325 treatment days Infants will be randomized to conventional phototherapy (new arm) Conventional phototherapy: Conventional phototherapy unit will be used for infants randomized to this arm for 1 to 10 days.
Safety of Phototherapy	268 treatment days	325 treatment days

PRIMARY outcome

Timeframe: Four to ten days

Population: The efficacy analysis was carried out on the 561 treatment days which were evaluable (see flow chart).

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=250 treatment days Window tinting film will be used. Window tinting film for filtered sunlight phototherapy: Six hours per day of filtered sunlight phototherapy for 1 to 10 days.	Conventional Phototherapy n=311 treatment days Infants will be randomized to conventional phototherapy (new arm) Conventional phototherapy: Conventional phototherapy unit will be used for infants randomized to this arm for 1 to 10 days.
Efficacy of Phototherapy	232 treatment days	280 treatment days

SECONDARY outcome

Timeframe: Four to ten days

Population: The need for exchange blood transfusion was assessed on all 447 enrolled participants.

Exchange blood transfusion required to lower the bilirubin level. Serum bilirubin will be measured twice daily during filtered sunlight or conventional phototherapy exposure, for an expected average of four days, and a maximum of ten days.

Outcome measures

Outcome measures
Measure	Filtered Sunlight Phototherapy n=224 Participants Window tinting film will be used. Window tinting film for filtered sunlight phototherapy: Six hours per day of filtered sunlight phototherapy for 1 to 10 days.	Conventional Phototherapy n=223 Participants Infants will be randomized to conventional phototherapy (new arm) Conventional phototherapy: Conventional phototherapy unit will be used for infants randomized to this arm for 1 to 10 days.
Number of Participants Requiring Exchange Blood Transfusion	0 Participants	0 Participants

Adverse Events

Filtered Sunlight Phototherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional 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 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