Effect of Phototherapy on Serum Calcium

Phototherapy Clinical Trial

Official title:

Effect of Phototherapy on Serum Level of Calcium in Infants With Hyperbilirubinemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04215601
• Other study ID #: pt effect on calcium
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: February 20, 2022

Study information

• Verified date: February 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 20, 2022
• Est. primary completion date: February 10, 2022
• Gender: All
• Age group: 1 Hour to 30 Days

Eligibility

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.

Related Conditions & MeSH terms

• Phototherapy
• Side Effects

Locations

Country	Name	City	State
Egypt	Assiut children's hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

Alizadeh-Taheri P, Sajjadian N, Eivazzadeh B. Prevalence of phototherapy induced hypocalcemia in term neonate. Iran J Pediatr. 2013 Dec;23(6):710-1. No abstract available. — View Citation

Amos RC, Jacob H, Leith W. Jaundice in newborn babies under 28 days: NICE guideline 2016 (CG98). Arch Dis Child Educ Pract Ed. 2017 Aug;102(4):207-209. doi: 10.1136/archdischild-2016-311556. Epub 2017 Feb 8. No abstract available. — View Citation

Hansen TW. [Treatment of neonatal jaundice]. Tidsskr Nor Laegeforen. 2005 Mar 3;125(5):594-8. Norwegian. — View Citation

Kargar M, Jamshidi Z, Beheshtipour N, Pishva N, Jamali M. Effect of head covering on phototherapy-induced hypocalcaemia in icterus newborns; a randomized controlled trial. Int J Community Based Nurs Midwifery. 2014 Apr;2(2):121-6. — View Citation

Shahriarpanah S, Haji Ebrahim Tehrani F, Davati A, Ansari I. Effect of Phototherapy on Serum Level of Calcium, Magnesium and Vitamin D in Infants With Hyperbilirubinemia. Iran J Pathol. 2018 Summer;13(3):357-362. Epub 2018 Sep 12. — View Citation

Waterham M, Bhatia R, Donath S, Molesworth C, Tan K, Stewart M. Phototherapy in transport for neonates with unconjugated hyperbilirubinaemia. J Paediatr Child Health. 2016 Jan;52(1):67-71. doi: 10.1111/jpc.12984. Epub 2015 Aug 19. — View Citation

Xiong T, Tang J, Mu DZ. [Side effects of phototherapy for neonatal hyperbilirubinemia]. Zhongguo Dang Dai Er Ke Za Zhi. 2012 May;14(5):396-400. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum calcium level after 48 hours of phototherapy	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	2days