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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR935 |
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Date of registration:
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13/03/2007 |
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Primary sponsor: |
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Public title:
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Reducing bilirubin induced neurological dysfunction in preterm infants:
additional use of the bilirubin:albumin ratio in the treatment of hyperbilirubinemia.
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Scientific title:
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Reducing bilirubin induced neurological dysfunction in preterm infants:
additional use of the bilirubin:albumin ratio in the treatment of hyperbilirubinemia.
- BARTrial |
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Date of first enrolment:
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1/4/2007 |
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Target sample size:
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614 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=935 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Deirdre
Imhoff van |
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Address:
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Beatrix Children's Hospital,
University Medical Center Groningen
Hanzeplein 1
PO box 30.001
9700 RB
Groningen
The Netherlands |
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Telephone:
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+31 50 3614215 |
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Email:
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d.e.van.imhoff@bkk.umcg.nl |
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Affiliation:
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Name:
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Peter
Dijk |
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Address:
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Beatrix Children's Hospital,
University Medical Center Groningen
Hanzeplein 1
PO box 30.001
9700 RB
Groningen
The Netherlands |
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Telephone:
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+31 50 - 3614215 |
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Email:
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p.h.dijk@bkk.umcg.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Preterm infants born at gestational age less than 32 weeks;
2. Admittance in the first 24 hours of life to a neonatal intensive care unit care center in the Netherlands.
Exclusion criteria: 1. Major congenital malformations, clinical syndromes and chromosomal abnormalities that effect neurodevelopmental outcome.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Premature infants, Prematurity, Hyperbilirubinemia, Bilirubin:albumin ratio, Bilirubin, Neurodevelopmental outcome
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Intervention(s)
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Studygroup: Hyperbilirubinemia is evaluated daily, in the first 10 days of life using the B:A ratio together with TSB. Treatment guidelines (phototherapy and exchange transfusion limits) are based on B:A ratio and TSB (whichever comes first)
Controlgroup: Hyperbilirubinemia is evaluated daily, in the first 10 days of life using TSB only (care as usual).
versus only TSB. Treatment guidelines (phototherapy and exchange transfusion limits) are based on TSB only.
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Primary Outcome(s)
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Blinded assessment of the participants outcome is performed.
Primary outcome:
1. Neurodevelopmental outcome at the age of 18-24 months using standardised neurological examination;
2. Mental - and psychomotor developmental index scores (MDI and PDI: Dutch version of Bayley scales of infant development II)
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Secondary Outcome(s)
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Secondary outcome:
1. Peak total serum bilirubin, duration of hyperbilirubinemia, duration of fototherapy, number of exchange transfusions;
2. Other outcomes are: complications of prematurity such as mortality, BPD, PDA, BPD, ROP, NEC, IVH ect.;
3. Other potential outcomes to be evaluated in parts of the study population are: maturation pattern of serial auditory brainstem responses (ABR) in a part of the study populations that is treated in those NICU?s that are able to perform serial ABR?s. free (unbound) unconjugated bilirubin, lumirubin, CFM, movement scores
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Secondary ID(s)
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ISRCTN74465643
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development
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