Aluminium Foil as an Adjuvant to Phototherapy for Patholo... | NCT04433923

Studies
Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants

NCT04433923

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Jun 16, 2020Actual

Enrollment

Not provided

Phase

Not Applicable

Conditions

Neonatal Jaundice

Interventions

Phototherapy with aluminum foil
Phototherapy without aluminum foil

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2016

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Dec 1, 2018Actual

First Submitted Date

Jun 13, 2020

First Submission Date that Met QC Criteria

Jun 13, 2020

First Posted Date

Jun 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2020

Last Update Posted Date

Jun 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

prospective single center pilot randomized open label clinical trial, conducted at the Neonatal care unit of Mansoura University Children's To assess the efficacy and safety of aluminum foil use in combination with phototherapy compared with phototherapy alone for pathological unconjugated hyperbilirubinaemia in full term newborn We enrolled 234 infants in the study who fulfilled the inclusion criteria and were randomly assigned to treatment groups, either conventional phototherapy with aluminum foil or conventional phototherapy alone.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GROUP1	Active Comparator	Phototherapy with aluminum foil	Device: Phototherapy with aluminum foil
GROUP2	Placebo Comparator	Phototherapy without aluminum foil	Device: Phototherapy without aluminum foil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phototherapy with aluminum foil	Device		GROUP1
Phototherapy without aluminum foil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total serum bilirubin	measurement of Total serum bilirubin (mg/dl)	8 hours of treatment
Total serum bilirubin	measurement of Total serum bilirubin (mg/dl)	24 hours of treatment
Total serum bilirubin	measurement of Total serum bilirubin (mg/dl)	48 hours of treatment

Secondary Outcomes

Measure	Description	Time Frame
duration of photo therapy	duration of photo therapy in hours	average 48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinaemia who are candidate for photo therapy according to American academy guidelines

Exclusion Criteria:

Preterm infants, newborn infant with congenital malformations, conjugated hyperbilirubinamia, small for gestational age, in need of exchange transfusion, and skin abrasions or infections

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

28 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007567	Jaundice, Neonatal

Ancestor Terms

ID	Term
D051556	Hyperbilirubinemia, Neonatal
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006932	Hyperbilirubinemia

Browse Leaves

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Browse Branches

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