NCT04215601

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

December 29, 2019

Last Update Submit

February 6, 2023

Conditions

PhototherapySide Effects

Keywords

phototherapyhypocalcemia

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age1 Hour - 30 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants who will come at neonatal unit of Assiut University Children's Hospital meeting our inclusion criteria.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut children's hospital

Asyut, 71515, Egypt

Location

Related Publications (7)

  • 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.

    PMID: 28179382BACKGROUND

  • 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.

    PMID: 24910756BACKGROUND

  • 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.

    PMID: 30636959BACKGROUND

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

    PMID: 15776035BACKGROUND

  • 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.

    PMID: 26289553BACKGROUND

  • 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.

    PMID: 22613117BACKGROUND

  • 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.

    PMID: 25349853BACKGROUND

MeSH Terms

Conditions

Hypocalcemia

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

December 29, 2019

First Posted

January 2, 2020

Study Start

February 1, 2020

Primary Completion

February 10, 2022

Study Completion

February 20, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

EG(1)