NCT01550627

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
Last Updated

March 12, 2012

Status Verified

March 1, 2012

Enrollment Period

1.6 years

First QC Date

February 7, 2012

Last Update Submit

March 9, 2012

Conditions

Hyperbilirubinemia

Keywords

preterm infants < 32 weeks of gestation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

extra-fluid

ACTIVE COMPARATOR

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

non extra fluid (control group)

PLACEBO COMPARATOR

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

Interventions

extra fluid/iv fluid supplementation during phototherapyOTHER

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.

extra-fluid
Non extra fluidOTHER

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.

non extra fluid (control group)

Eligibility Criteria

Age1 Week - 1 Week
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Hyperbilirubinemia

You may not qualify if:

  • Preterm infants \> 33 weeks of gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Jena

Jena, Jena, 07743, Germany

Location

MeSH Terms

Conditions

Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
(MD)

Study Record Dates

First Submitted

February 7, 2012

First Posted

March 12, 2012

Study Start

November 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

March 12, 2012

Record last verified: 2012-03

Locations

DE(1)