Reducing bilirubin induced neurological dysfunction in preterm infants: additional use of the bilirubin:albumin ratio in the treatment of hyperbilirubinemia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26621

Enrollment

614

Registered

2007-03-13

Start date

2007-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

English: Infants premature, preterm infant, hyperbilirubinemia, bilirubin:albumin ratio, albumin. BIND, bilirubin induced neurological dysfunction. Neurodevelopmental outcome. Nederlands: prematuur, prematuriteit, hyperbilirubinemie, bilirubine:albumine ratio, albumine, BIND, bilirubine geinduceerde neurologische dysfunctie. Neurologische ontwikkeling.

Interventions

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

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Major congenital malformations, clinical syndromes and chromosomal abnormalities that effect neurodevelopmental outcome.

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactDeirdre Imhoff van

Beatrix Children's Hospital, University Medical Center Groningen Hanzeplein 1 PO box 30.001

d.e.van.imhoff@bkk.umcg.nl+31 50 3614215

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)