Effect of Phototherapy on Serum Calcium

Completed

• Conditions: Phototherapy; Side Effects

• Registration Number: NCT04215601
• Lead Sponsor: Assiut University

Brief Summary

Through this study our aim was to evaluate whether significant change in serum calcium level occurs in term newborns who are undergoing phototherapy and to find out the association between effect of phototherapy on serum calcium level and birth weight, postnatal age and type of feeding.

Detailed Description

Jaundice is the yellow discoloration of skin, sclerae, and other tissues caused by the deposition of bilirubin.

Approximately 60% of term and 80% of preterm babies develop jaundice in the first week of life, and about 10% of breastfed babies are still jaundiced at 1 month. Jaundice is a common cause of readmission to hospital after early discharge of newborn infants.

The most common form of hyperbilirubinaemia observed in neonates is due to unconjugated or unbound bilirubin. High levels of unconjugated bilirubin are managed by treatment of the underlying cause (e.g. dehydration and sepsis), provision of phototherapy, administration of immunoglobulin (in certain cases of haemolytic anaemia) and, in very severe cases, exchange transfusion. If left untreated, extreme elevation of unconjugated bilirubin can lead to permanent brain damage (kernicterus) and/or death.

However, exchange transfusion is associated with a significant morbidity, and even mortality while phototherapy has several disadvantages which include increasing the duration of hospitalization, costs and mother-child separation . It also has some reported side effects as rash, loose green stools, dehydration, ocular hazards, oxidative injury, hyperthermia and water loss and may be associated with some long-term side effects such as melanocytic nevi, skin cancer, allergic disease, patent ductus arterious and retinal damage .

Some studies are available concerning the prevalence of hypocalcemia in neonates after phototherapy, but the results varied based on where the studies were conducted. So, more studies were required to reach a definite conclusion. Through this study our aim was to evaluate whether significant change in serum calcium level occurs in term newborns who are undergoing phototherapy and to find out the association between effect of phototherapy on serum calcium level and birth weight, postnatal age and type of feeding.

Study Timeline

• Study First Submitted: 2019-12-29
• Study First Submitted QC: 2019-12-29
• Study First Posted: 2020-01-02
• Study Start: 2020-02-01
• Primary Completion: 2022-02-10
• Study Completion: 2022-02-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Stable term neonates with jaundice who require management with phototherapy and are fed with full strength formula or breast fed.

Exclusion Criteria

• Jaundiced neonates with hypocalcemia.
• Jaundiced neonates needing exchange transfusion.
• Jaundiced neonates suffering from hypothyroidism.
• Jaundiced infants of diabetic mother.
• Jaundiced infants with other illness as severe RDS, perinatal asphyxia,Sever sepsis or hemolytic disease of newborn.
• Jaundiced infants with congenital abnormalities.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum calcium level after 48 hours of phototherapy	2days	The neonates under study will be compared regarding serum bilirubin level and serum calcium level prior to start of study and then repeated after 48 hours to show any significant change in serum calcium level after exposure to phototherapy

Trial Locations

Locations (1)

Assiut children's hospital; 🇪🇬 Assiut, Egypt