Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000138583
Ethics application status
Approved
Date submitted
27/03/2006
Date registered
24/04/2006
Date last updated
28/08/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of different levels of incubator humidity on temperature and fluid and electrolyte balance in infants born at 28 weeks gestation and less.
Scientific title
Effects of different levels of incubator humidity on temperature and fluid and electrolyte balance in infants born at 28 weeks gestation and less.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infants born at 28 weeks gestation and less. 1107 0
Condition category
Condition code
Reproductive Health and Childbirth 1187 1187 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study compares the effects of two different levels of incubator humidity (70%, and 80% relative humidity) on temperature control and fluid and electrolyte balance in preterm infants born at 28 weeks gestation and less.
The duration of the study is 14 days.
Intervention code [1] 903 0
None
Comparator / control treatment
80% incubator humidity
we start nursing the baby in humidity once the baby is transferred into the isolette.
The baby will be nursed in 80% incubator humidity for seven days. From day 8 onwards, we'll start to decrease the incubator humidity by 10% each day. When the humidity is down to 40% and the baby's body temperature is stable, we'll cease the incubator humidity. We'll be collecting data on the baby's body temperature for 14 days, so the total duration of the study is 14 days.
Control group
Dose comparison

Outcomes
Primary outcome [1] 1601 0
The primary outcome is to compare the temperature variability in preterm infants nursed in 70% or 80% incubator humidity. This will be reflected by the number of documented low body temperature (<36 degree C) on each day for the first seven days after birth
Timepoint [1] 1601 0
On each day for the first seven days after birth
Secondary outcome [1] 2897 0
1) To compare the degree of evaporative water loss in preterm infants nursed in 70% or 80% incubator humidity in terms of daily fluid requirement, variability from normal serum sodium ranges, and skin integrity.
Timepoint [1] 2897 0
Daily for the first 14 days after birth.
Secondary outcome [2] 2898 0
2) To compare the incidences of positive bacterial cultures from incubators in 70% and 80% incubator humidity.
Timepoint [2] 2898 0
At the start of the study and on day 14.
Secondary outcome [3] 2899 0
3) To compare the difference of visibility of the infant nursed in the two different levels of incubator humidity.
Timepoint [3] 2899 0
Daily for the first seven days after birth.

Eligibility
Key inclusion criteria
All preterm infants born at 28 weeks gestation and less who are clinically stable enough to be nursed in a closed incubator by 48 hours of age.
Minimum age
0 Days
Maximum age
2 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Critically ill preterm infants >48 hours of age who continue to be nursed under radiant warmers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by coin-tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1298 0
Hospital
Name [1] 1298 0
Newborn Services, Monash Medical Centre, Southern Health
Country [1] 1298 0
Australia
Primary sponsor type
Individual
Name
Ms Alison Medhurst, Nurse Unit Manager, Newborn Services, Southern Health
Address
246 Clayton road, Clayton Vic. 3168
Country
Australia
Secondary sponsor category [1] 1146 0
None
Name [1] 1146 0
Nil
Address [1] 1146 0
Country [1] 1146 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The purpose of the protocol is to examine the effects of two levels of commonly used ambient humidity (70% and 80%) in the incubator on
1) body temperature control
2) fluid and electrolyte balance
3)bacterial colonisation and visibility as a
result of water condensation
in preterm infants born at 28 weeks gestation and less. This information will be used as a basis for a unit protocol for nursing preterm infants in humidity.
We hypothesize that in the first two weeks of life after birth, there is no significant difference in body temperature stability when nursing preterm infants in either 70% or 80% incubator humidity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35565 0
Address 35565 0
Country 35565 0
Phone 35565 0
Fax 35565 0
Email 35565 0
Contact person for public queries
Name 10092 0
Yuk-Shan KONG
Address 10092 0
Monash Medical Centre
Southern Health
246 Clayton Road
Clayton VIC 3168
Country 10092 0
Australia
Phone 10092 0
+61 3 95945181
Fax 10092 0
+61 3 95946115
Email 10092 0
YukShan.Kong@southernhealth.org.au
Contact person for scientific queries
Name 1020 0
Yuk-Shan KONG
Address 1020 0
Monash Medical Centre
Southern Health
246 Clayton Road
Clayton VIC 3168
Country 1020 0
Australia
Phone 1020 0
+61 3 95945181
Fax 1020 0
+61 3 95946115
Email 1020 0
YukShan.Kong@southernhealth.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.