Reducing bilirubin-induced neurological dysfunction (BIND) in premature newborns, additional use of bilirubin:albumin ratio in the treatment of hyperbilirubinemia

Reducing bilirubin-induced neurological dysfunction (BIND) in premature newborns, additional use of bilirubin:albumin ratio in the treatment of hyperbilirubinemia - Reducing BIND in premature newborns

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30420

Enrollment

614

Registered

2007-01-09

Start date

2007-05-01

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

hyperbilirubinemie en ontwikkelingsachterstand hyperbilirubinemia neonatal jaundice

Interventions

Hyperbilirubinemia is evaluated daily using the B:A ratio together with TSB (study group) versus TSB only (control or care-as-usual group). Treatment guidelines are based on B:A ratio and TSB (which

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Prematurity

Exclusion criteria

Exclusion criteria: major congenital malformations, clinical syndromes and chromosomal abnormalities

Design outcomes

Primary

Measure	Time frame
Primairy outcome variables are: neurodevelopmental outcome at 18-24 months of age using standardized neurological examination and mental- and psychomotor developmental index scores (MDI and PDI).	—

Secondary

Measure	Time frame
Secondary outcome variables are peak TSB, peak B:A ratio, duration of hyperbilirubinemia, number and duration of phototherapy, number exchange transfusions, and the standard complications of prematurity such as mortality, RDS, BPD, ROP, NEC, IVH, PVE/PVL etcetera.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)