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

University of Jena

Status and phase: Completed; Early Phase 1

Conditions: Hyperbilirubinemia

Treatments: Other: Non extra fluid; Other: extra fluid/iv fluid supplementation during phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01550627

2127-10/09

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 1 to 1 week old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hyperbilirubinemia

Exclusion criteria

• Preterm infants > 33 weeks of gestation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

extra-fluid

Active Comparator group

Description:

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).

Treatment:

Other: extra fluid/iv fluid supplementation during phototherapy

non extra fluid (control group)

Placebo Comparator group

Description:

The control group received the previous fluid regime, as intravenous fluid was given constantly, without a specific guideline according to extra fluid intake.

Treatment:

Other: Non extra fluid