Safety and Efficacy of intermittent versus continuous phototherapy to treat neonatal hyperbilirubinemia: a randomized prospective clinical study

Safety and Efficacy of intermittent versus continuous phototherapy to treat neonatal hyperbilirubinemia: a randomized prospective clinical study - iPT versus CPT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036929

Enrollment

444

Registered

2025-05-15

Start date

2025-09-09

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P59

Interventions

Group 1: Intermittent phototherapy Group 2: Continuous phototherapy

Eligibility

Sex/Gender

All

Age

0 Days to 14 Days

Inclusion criteria

Inclusion criteria: Gestational age =35+0 weeks or 24+0 to 27+6 weeks Phototherapy indication according to AWMF guideline Written informed consent by legal guardians

Exclusion criteria

Exclusion criteria: Jaundice onset before 36 hours of life (Ikterus praecox) First phototherapy > day 14 of life (Ikterus prolongatus) Planned blood transfusions or surgeries during study phase Severe congenital anomalies (EUROCAT definition) Chromosomal aberrations affecting outcome or phototherapy efficacy Bilirubin level <2 mg/dl below exchange transfusion threshold

Design outcomes

Primary

Measure	Time frame
Non-inferiority of intermittent phototherapy compared to continuous phototherapy in terms of its effectiveness, measured by the reduction in bilirubin levels during treatment. The endpoint is defined as a sufficient decrease in serum bilirubin concentration to below the treatment threshold as defined by the AWMF guideline. For the group of late preterm and term neonates (=35+0 weeks of gestation), this corresponds to an average reduction of =3 mg/dl. For the group of very preterm infants (24+0 to 27+6 weeks of gestation), an average reduction of =1 mg/dl is required. Assessment takes place 6 and 24 hours after the start of phototherapy, as well as 8 hours after the end of therapy to monitor for potential rebound of bilirubin levels. Bilirubin levels are determined via laboratory analysis of venous or capillary blood samples. The measurements are part of routine clinical monitoring, performed in accordance with the AWMF guideline and local standard operating procedures (SOPs). No additional blood samples are collected for study purposes. The evaluation is based on values recorded in the hospital’s laboratory information system.	—

Measure

Time frame

Non-inferiority of intermittent phototherapy compared to continuous phototherapy in terms of its effectiveness, measured by the reduction in bilirubin levels during treatment. The endpoint is defined as a sufficient decrease in serum bilirubin concentration to below the treatment threshold as defined by the AWMF guideline. For the group of late preterm and term neonates (=35+0 weeks of gestation), this corresponds to an average reduction of =3 mg/dl. For the group of very preterm infants (24+0 to 27+6 weeks of gestation), an average reduction of =1 mg/dl is required. Assessment takes place 6 and 24 hours after the start of phototherapy, as well as 8 hours after the end of therapy to monitor for potential rebound of bilirubin levels. Bilirubin levels are determined via laboratory analysis of venous or capillary blood samples. The measurements are part of routine clinical monitoring, performed in accordance with the AWMF guideline and local standard operating procedures (SOPs). No additional blood samples are collected for study purposes. The evaluation is based on values recorded in the hospital’s laboratory information system.

—

Secondary

Measure	Time frame
Treatment failure, breastfeeding frequency, kangaroo care, parental presence and satisfaction, vital parameters (in preterm infants), weight development, hospitalization duration, side effects (e.g., temperature deviations, electrolyte disturbances), readmission	—

Countries

Germany

Contacts

Public ContactEva-Maria Mair

Univeristätsklinikum Ulm

harald.ehrhardt@uniklinik-ulm.de+49731 500 57168

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026