BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator

NCT03942757 | Completed

• 1 other identifier: PI2018_843_0021
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Phototherapy is routinely used in neonatal intensive care units for the treatment of jaundice. Guidelines focus mainly on bilirubin serum levels to start the phototherapy. Only few data are available about clinical management of phototherapy devices and subsequently the impact on bilirubin serum decrease. Especially there are no strong recommendations about phototherapy duration, irradiance measurements, incubator temperature and humidity settings. Various factors can influence irradiance and thus the preterm infant bilirubin serum decrease. This study aims at evaluating the impact of an educational program on the use and efficacy of phototherapy in a neonatal intensive care unit.

Conditions

Preterm Infant; Jaundice, Neonatal; Phototherapy

Keywords

preterm infant; jaundice; bilirubin; phototherapy; educational program

Outcome Measures

Primary Outcomes (1)

• Change in bilirubin serum level (μmol/L/h)

  Change in bilirubin serum level (μmol/L/h) = (end bilirubin (μmol/L) - start bilirubin (μmol/L)) / delay between the 2 measurements (h)

  before and 24 hours after start of phototherapy treatment

Study Arms (2)

observation before educational program

100 preterm infant medical records will be studied in a first part of this observational study

Other: bilirubin serum level determination; Other: Phototherapy

Observation after educational program

An educational program will be implemented in the unit after this first period. 100 preterm infant will be included in a second part of this observational study.

Other: bilirubin serum level determination; Other: Phototherapy

Interventions

bilirubin serum level determination OTHER

bilirubin serum level before and after phototherapy treatment will be measured

Observation after educational program; observation before educational program

Phototherapy OTHER

Preterm infant \< 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment.

Observation after educational program; observation before educational program

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Prospective, monocentric, observational study. All the preterm infant with a jaundice requiring a treatment with phototherapy could been screened for eligibility criteria

You may qualify if:

• preterm infant less than 35 weeks gestation
• preterm infant hospitalized in the neonatal intensive care unit of CHU Amiens-Picardie
• preterm infant placed in an incubator
• preterm infant with a jaundice requiring treatment according to NICE guidelines
• preterm infant with a no hemolytic disease
• preterm infant with informed written consent from the parents

You may not qualify if:

• preterm infant more than 35 weeks of gestation
• preterm infant with hemolytic disease
• preterm infant with Jaundice related to a cholestasis
• Jaundice requiring exchange transfusion

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Premature Birth; Jaundice, Neonatal; Jaundice

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 8, 2019
• Study Start: May 2, 2019
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)