Clinical trial NCT04215601: Effect of Phototherapy on Serum Calcium
Official title: Effect of Phototherapy on Serum Level of Calcium in Infants With Hyperbilirubinemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phototherapy
Side Effects
Keywords: phototherapy
hypocalcemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants who will come at neonatal unit of Assiut University Children's Hospital meeting our inclusion criteria.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum calcium level after 48 hours of phototherapy
timeFrame: 2days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut children's hospital
Study officials:
References:
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.
citation: 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.
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.
citation: Hansen TW. [Treatment of neonatal jaundice]. Tidsskr Nor Laegeforen. 2005 Mar 3;125(5):594-8. Norwegian.
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.
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.
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.