Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
40 participants
OBSERVATIONAL
2020-02-01
2022-02-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Intravenous Fluid Supplementation on Serum Bilirubin and Cardiorespiratory Parameters in Preterm Infants During Phototherapy
NCT01550627
Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice
NCT06386731
Conventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia
NCT04373980
Accuracy of TcB Measurements During and After Phototherapy
NCT07080398
High Intensity Phototherapy: Double vs. Single
NCT02805296
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
1 Hour
30 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
A.L.Mohamed
Resident doctor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Assiut children's hospital
Asyut, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Hansen TW. [Treatment of neonatal jaundice]. Tidsskr Nor Laegeforen. 2005 Mar 3;125(5):594-8. Norwegian.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
pt effect on calcium
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.