Clinical Trials Directory

Trials / Completed

CompletedNCT04215601

Effect of Phototherapy on Serum Calcium

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

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
1 Hour – 30 Days
Healthy volunteers

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.

Conditions

Timeline

Start date
2020-02-01
Primary completion
2022-02-10
Completion
2022-02-20
First posted
2020-01-02
Last updated
2023-02-08

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04215601. Inclusion in this directory is not an endorsement.