NCT01550627

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

Study of Possible Effects of Intravenous Fluid Supplementation on Serum Bilirubin Levels and Cardiorespiratory Parameters in Preterm Infants During Phototherapy

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Jena · Academic / Other
• Sex: All
• Age: 1 Week – 1 Week
• Healthy volunteers: Not accepted

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

Conditions

• Hyperbilirubinemia

Interventions

Type	Name	Description
OTHER	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). The extra fluid intake was interrupted during the 12 hours break of phototherapy.
OTHER	Non extra fluid	Control placebo The control group received the previous fluid regime, as intravenous fluid was given constantly, without a specific guideline according to extra fluid intake.

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2012-03-12
• Last updated: 2012-03-12

Locations

1 site across 1 country: Germany