Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-1
SponsorAmira Adel Fouly

About this trial

Neonatal jaundice, or neonatal hyperbilirubinemia, is a common medical issue in the first two weeks of life, causing prolonged hospitalization and readmissions. It results from elevated total serum bilirubin (TSB) and is manifested as yellowish discoloration of the skin, sclera, and mucous membrane. Clinical jaundice appears in about 60% of term neonates and 80% of preterm infants within the first week of life. Pathologic hyperbilirubinemia occurs when bilirubin levels increase by more than 5 mg/dL/day or 0.2 mg/dL/hour, or when jaundice lasts longer than two to three weeks in full-term infants. In preterm infants, unconjugated hyperbilirubinemia is of particular concern due to their permeable blood-brain barrier and underdeveloped brain. Phototherapy is widely used to reduce or prevent the rise of serum unconjugated bilirubin levels and reduce the need for exchange transfusions. However, phototherapy has both immediate and long-term side effects, and it can only decrease accumulated UCB but does not prevent its accumulation. There is a growing potential to explore novel adjuvant treatments to increase bilirubin clearance, decrease phototherapy duration, and decrease exchange transfusion rate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

neonates with both genders

neonates with gestational age ≥ 32 weeks

neonates who can tolerate enteral feeding

diagnosed with unconjugated non-hemolytic hyperbilirubinemia

Disqualifiers

Neonates with seizures, hydrops fetalis, hypoxic-ischemic encephalopathy, or major congenital anomalies

Neonates who have had an exchange transfusion within 24 hours

neonates have evidence of hemolytic causes of jaundice (e.g., ABO and RH

incompatibility, glucose 6-phosphate dehydrogenase deficiency)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zinc sulfate

    Drug

    Neonates will receive oral Zn sulfate solution in either low doses (10 mg/day) or high doses (20 mg/day) given twice daily.

  • Ursodeoxycholic acid

    Drug

    Neonates will receive oral UDCA solution at 10 mg/day given as 5 mg twice daily.

Treatment groups

80 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: preterm: controlNo intervention 0 interventions
Group B: preterm: low dose of oral zinc sulfateExperimental treatment 1 intervention
Group C: preterm: high dose of oral zinc sulfateExperimental treatment 1 intervention
Group D: preterm: low dose of oral UDCAExperimental treatment 1 intervention
Group E: full-term: controlNo intervention 0 interventions
Group F: full-term: low dose of oral zinc sulfateExperimental treatment 1 intervention
Group G: full-term: high dose of oral zinc sulfateExperimental treatment 1 intervention
Group H: full-term: low dose of oral UDCAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

serum bilirubin level.

Assessing the effect of oral administration of zinc sulfate (at low and high doses) and ursodeoxycholic acid on serum bilirubin levels during the treatment of neonatal non-hemolytic unconjugated hyperbilirubinemia.

Time frame
10 days
2

duration of phototherapy needed.

Assessing the effect of oral administration of zinc sulfate (at low and high doses) and ursodeoxycholic acid on the duration of phototherapy during the treatment of neonatal non-hemolytic unconjugated hyperbilirubinemia.

Time frame
10 days

Secondary outcomes

1

monitoring adverse effects

assessing the possible side effects of both drugs

Time frame
10 days
2

serum zinc level

evaluate the level of serum zinc before and after interventions.

Time frame
10 days
3

length of NICU stay.

assess if the intervention will affect the duration of the NICU stay.

Time frame
10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amira Adel Fouly

Lead sponsor

Future University in Egypt

Sponsor institution

Egyptian Chinese University

Collaborator

Ain Shams University

Collaborator