Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000518561
Ethics application status
Approved
Date submitted
26/08/2003
Date registered
26/08/2003
Date last updated
25/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Transfer of preterm infants from incubator to open cot at a lower body weight (1600g) versus a higher body weight (1800g)
Scientific title
A randomised controlled trial of transferring preterm infants born less than 1600g, from incubator to open cot at lower (1600g) versus higher (1800g) body weight to determine the effects on weight gain, temperature stability and length of hospital stay
Secondary ID [1] 33 0
Perinatal Trials Registry: PTR427
Universal Trial Number (UTN)
Trial acronym
TIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premature infants 34 0
Condition category
Condition code
Reproductive Health and Childbirth 40 40 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 41 41 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intervention group- will remain in the incubator until the weight reaches greater than or equal to 1600 grams at which time they will be transferred to and nursed in an open cot until discharge
Intervention code [1] 1110 0
Other interventions
Comparator / control treatment
control group- will remain in the incubator until the weight reaches greater than or equal to 1800 grams at which time they will be transferred to and nursed in an open cot until discharge
Control group
Active

Outcomes
Primary outcome [1] 69 0
Infants temperature stability
Timepoint [1] 69 0
Measured at one hour post transfer to an open cot and then third hourly for the first 72 hours and then eighth hourly until discharge
Primary outcome [2] 70 0
Average daily weight gain over the first 14 days following transfer to an open cot.
Timepoint [2] 70 0
Over the first 14 days following transfer to an open cot
Secondary outcome [1] 125 0
Proportion of infants requiring an overhead heater for temperature maintenance.
Timepoint [1] 125 0
Measured at one hour post transfer to an open cot then third hourly for the first 72 hours and then eighth hourly until discharge.
Secondary outcome [2] 126 0
Proportion of infants requiring to be returned to an incubator for temperature maintenance.
Timepoint [2] 126 0
Measured at one hour post transfer to an open cot then third hourly for the first 72 hours and then eighth hourly until discharge.
Secondary outcome [3] 127 0
Time to discharge from Royal Brisbane & Women’s Hospital and referral hospital (from time of group allocation)
Timepoint [3] 127 0
Measured as date of discharge from the Royal Brisbane & Women's Hospital
Secondary outcome [4] 128 0
Age at discharge home
Timepoint [4] 128 0
Measured as gestational age in weeks and days at the time of discharge from a hospital
Secondary outcome [5] 129 0
Weight at discharge home
Timepoint [5] 129 0
Measured as weight in grams at the time of discharge home from a hospital

Eligibility
Key inclusion criteria
Preterm infants, both male and female, with a birthweight of less than 1600 grams - weight <1600 grams at enrolment- >=48 hours age,- >= 48 hours without requiring assisted ventilation or Continuous Positive Airway Pressure (CPAP)- medically stable- receiving enteral calorie intake of at least 60 mls/kg/day, and- at least one parent who can understand written or spoken English.
Minimum age
2 Days
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Requiring assisted ventilation or CPAP,- medically unstable,- oxygen via cot or sub nasal prongs,- major congenital abnormality.

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 opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician managed sequence generation, using a computer generated random number sequence. Stratified allocation by birth weight (BW) (<1000g or >=1000g) and gestational age (GA) at birth (<34 weeks or >=34 weeks) have been used. Therefore each preterm infant will belong to one of the four following strata: <1000g and <34 weeks; >=1000g and <34 weeks; <1000g and >=34 weeks; >=1000g and <34 weeks and will be randomly allocated to the control vs intervention group within each stratum.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/06/2003
Actual
7/07/2003
Date of last participant enrolment
Anticipated
30/06/2005
Actual
13/02/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
182
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 57 0
Hospital
Name [1] 57 0
Division of neonatology, Royal Brisbane & Women's Hospital
Country [1] 57 0
Australia
Primary sponsor type
Hospital
Name
Division of neonatology, Royal Brisbane & Women's Hospital
Address
Butterfield Street
Herston Q 4029
Country
Australia
Secondary sponsor category [1] 42 0
None
Name [1] 42 0
Nil
Address [1] 42 0
Country [1] 42 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 366 0
Royal Brisbane & Women's Hospital
Ethics committee address [1] 366 0
Ethics committee country [1] 366 0
Australia
Date submitted for ethics approval [1] 366 0
Approval date [1] 366 0
10/04/2003
Ethics approval number [1] 366 0
2003/001
Ethics committee name [2] 367 0
Redcliffe & Caboolture Hospitals
Ethics committee address [2] 367 0
Ethics committee country [2] 367 0
Australia
Date submitted for ethics approval [2] 367 0
Approval date [2] 367 0
10/11/2004
Ethics approval number [2] 367 0
04/Dec/05
Ethics committee name [3] 368 0
Toowoomba Hospital
Ethics committee address [3] 368 0
Ethics committee country [3] 368 0
Australia
Date submitted for ethics approval [3] 368 0
Approval date [3] 368 0
30/05/2004
Ethics approval number [3] 368 0
042/2004

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35204 0
Dr Karen New
Address 35204 0
UQ School of Nursing, Midwifery and Social Work
Room 337, Level 3, Chamberlain Building, The University of Queensland QLD 4072
Country 35204 0
Australia
Phone 35204 0
+61733467041
Fax 35204 0
Email 35204 0
[email protected]
Contact person for public queries
Name 10299 0
Karen New
Address 10299 0
UQ School of Nursing, Midwifery and Social Work
Room 337, Level 3, Chamberlain Building, The University of Queensland QLD 4072
Country 10299 0
Australia
Phone 10299 0
+61733467041
Fax 10299 0
+61 7 36365259
Email 10299 0
[email protected]
Contact person for scientific queries
Name 1227 0
Karen New
Address 1227 0
UQ School of Nursing, Midwifery and Social Work
Room 337, Level 3, Chamberlain Building, The University of Queensland QLD 4072
Country 1227 0
Australia
Phone 1227 0
+61733467041
Fax 1227 0
+61 7 36365259
Email 1227 0
[email protected]

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.