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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hyperbilirubinemia

Intervention / Treatment
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* Other: extra fluid/iv fluid supplementation during phototherapy
* Other: Non extra fluid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hyperbilirubinemia Exclusion Criteria: Preterm infants > 33 weeks of gestation

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 1 Week

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: extra-fluid<br>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). | Other: extra fluid/iv fluid supplementation during phototherapy<br>* 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.<br>|
| Placebo Comparator: non extra fluid (control group)<br>The control group received the previous fluid regime, as intravenous fluid was given constantly, without a specific guideline according to extra fluid intake. | Other: Non extra fluid<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum total serum bilirubin levels | The maximum total serum bilirubin levels within on week after onset of phototherapy | within one week after onset of phototherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm infants < 32 weeks of gestation