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Completed

NCT Number: NCT01550627

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

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.

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Key information

Conditions

Hyperbilirubinemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 week–1 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Hospital of Jena

Jena, 07743, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hyperbilirubinemia

Exclusion criteria

  • Preterm infants > 33 weeks of gestation

Treatment and study plan

extra fluid/iv fluid supplementation during phototherapy

Other

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.

Non extra fluid

Other

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.

Primary outcomes

  1. The maximum total serum bilirubin levels

    Time frame: within one week after onset of phototherapy

    The maximum total serum bilirubin levels within on week after onset of phototherapy

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 12, 2012
Registry last updated
Mar 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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