Effect of palivizumab on respiratory syncytial virus-associated burden of disease – a randomized controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23199

Enrollment

452

Registered

2007-07-19

Start date

2007-10-01

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

1. Respiratory syncytial virus bronchiolitis

Interventions

Monthly injection of placebo or palivizumab 15 mg/kg during the winter season.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Gestational age 32-35 weeks.

Exclusion criteria

Exclusion criteria: 1. Severe congenital anomaly; 2. Congenital heart disease; 3. Down syndrome.

Design outcomes

Secondary

Measure	Time frame
1. Health-related quality of life at age 1,3 and 6 years; 2. Asthmatic symptoms at age 3 and 6 years measured by questionnaires.	—

Primary

Measure	Time frame
1. Number of wheezing days during the first year of life.	—

Contacts

Public ContactLouis Bont

Wilhelmina Children's hospital / UMC Utrecht Postbus 85090

l.bont@umcutrecht.nl+31 (0)88 7555555

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)