Effect of Intravenous Fluid Supplementation on Serum Bilirubin and Cardiorespiratory Parameters in Preterm Infants During Phototherapy

Early Phase 1

Completed

• Conditions: Hyperbilirubinemia
• Interventions: Other: extra fluid/iv fluid supplementation during phototherapy; Other: Non extra fluid

• Registration Number: NCT01550627
• Lead Sponsor: University of Jena

Brief Summary

The aim of the study was to evaluate the influence of a systematic extra intravenous fluid supplementation during phototherapy in comparison to a fluid supplementation due to short term demand in preterm infants.

Detailed Description

60 preterm infants (GA ≤ 32 week) were assigned randomly to either receive a fluid supplementation due to short term demand (control group, n=30;) or a 20% extra fluid supplementation (study group, n=30) during intermediate phototherapy.

Collected data:

* cardiorespiratory parameters(heart rate, blood pressure, SaO2 and capillary refill time, breathing rate, temperature) and a pain score was completed at the first day of phototherapy

* The maximum total serum bilirubin levels (TSB) within one week after onset of phototherapy

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2012-02-07
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-09
• Last Update Submitted: 2012-03-09
• Study First Posted: 2012-03-12
• Last Update Posted: 2012-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Hyperbilirubinemia

Exclusion Criteria

• Preterm infants > 33 weeks of gestation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
extra-fluid	extra fluid/iv fluid supplementation during phototherapy	The study group received an extra intravenous fluid intake of 20% of the total fluid demand per 24 hours of NaCl 0,9% during each two hour period of phototherapy (12h total per day).
non extra fluid (control group)	Non extra fluid	The control group received the previous fluid regime, as intravenous fluid was given constantly, without a specific guideline according to extra fluid intake.

Primary Outcome Measures

Name	Time	Method
The maximum total serum bilirubin levels	within one week after onset of phototherapy	The maximum total serum bilirubin levels within on week after onset of phototherapy

Trial Locations

Locations (1)

University Hospital of Jena; 🇩🇪 Jena, Germany