Trial Outcomes & Findings for Fluid Balance Study in Sick Neonates (NCT NCT00962754)

NCT ID: NCT00962754

Last Updated: 2014-05-07

Results Overview

Duration of hospital stay in days or duration of admission at the pediatric ward in days

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 170 participants
• Primary outcome timeframe: 1-8 months
• Results posted on: 2014-05-07

Participant Flow

Patients were recruited upon admission to our neonatal high care ward from June 2009 to March 2010

Participant milestones

Measure	Physician Insight Fluid Balance Physician has insight in the fluid balance chart	Physician no Insight Fluid Balance Chart physician does not have insight in the fluid balance chart
Overall Study STARTED	86	84
Overall Study COMPLETED	86	84
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fluid Balance Study in Sick Neonates

Baseline characteristics by cohort

Measure	Physician Insight Fluid Balance n=86 Participants physician has insight in the fluid balance data	Physician no Insight Fluid Balance Chart n=84 Participants physician does not have insight in the fluid balance data (fluid balance chart is blinded)	Total n=170 Participants Total of all reporting groups
Age, Categorical <=18 years	86 Participants n=5 Participants	84 Participants n=7 Participants	170 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	0.01 years STANDARD_DEVIATION 0 • n=5 Participants	0.01 years STANDARD_DEVIATION 0 • n=7 Participants	0.01 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	33 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	51 Participants n=7 Participants	100 Participants n=5 Participants
Region of Enrollment Netherlands	86 participants n=5 Participants	84 participants n=7 Participants	170 participants n=5 Participants

PRIMARY outcome

Timeframe: 1-8 months

Population: intention to treat analysis

Duration of hospital stay in days or duration of admission at the pediatric ward in days

Outcome measures

Measure	Intervention Group (no Insight in Fluid Balance) n=84 Participants physician has no insight in fluid balance chart, ie the fluid balance chart is masked	Control Group (Insight in Fluid Balance) n=86 Participants physician has insight in (full access to) the fluid balance chart data
Duration of Admission at the Ward in Days	9 number of days Interval 2.0 to 37.0	8 number of days Interval 2.0 to 27.0

SECONDARY outcome

Timeframe: during days of admission

prescription of diuretic therapy

Outcome measures

Measure	Intervention Group (no Insight in Fluid Balance) n=84 Participants physician has no insight in fluid balance chart, ie the fluid balance chart is masked	Control Group (Insight in Fluid Balance) n=86 Participants physician has insight in (full access to) the fluid balance chart data
Use of Diuretics	0 participants	0 participants

SECONDARY outcome

Timeframe: duration of admission

notifications of complications

Outcome measures

Measure	Intervention Group (no Insight in Fluid Balance) n=86 Participants physician has no insight in fluid balance chart, ie the fluid balance chart is masked	Control Group (Insight in Fluid Balance) n=84 Participants physician has insight in (full access to) the fluid balance chart data
Complications	2 participants	5 participants

Adverse Events

Physician Insight Fluid Balance

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Physician no Insight Fluid Balance Chart

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. J. Bekhof

Princess Amalia Children's Clinic, Isala Klinieken

Phone: 0031-38-4245050

Email: j.bekhof@isala.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place