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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
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01550627
Enrollment
60
Registered
2012-03-12
Start date
2007-11-30
Completion date
2009-06-30
Last updated
2012-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperbilirubinemia

Keywords

preterm infants < 32 weeks of gestation

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

Interventions

OTHERextra 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.

OTHERNon 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.

Sponsors

University of Jena
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 1 Weeks
Healthy volunteers
No

Inclusion criteria

* Hyperbilirubinemia

Exclusion criteria

* Preterm infants \> 33 weeks of gestation

Design outcomes

Primary

MeasureTime frameDescription
The maximum total serum bilirubin levelswithin one week after onset of phototherapyThe maximum total serum bilirubin levels within on week after onset of phototherapy

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026