Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation

CompletedOBSERVATIONAL
Enrollment

42

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Bronchial HyperreactivityInfant, Premature
Interventions
OTHER

Methacholine Challenge Test (MCT)

MCT challenge with determination of methacholine concentration that causes a 20% decrease from baseline FEV1 (forced expiratory volume in the 1st second of expiration) - PC20-FEV1 - is a well-documented method of assessing bronchial hyper-reactivity (BHR) in both adults and children. Our group has shown that the determination of PC20 by spirometry is feasible in preschool children. MCT is considered safe in this age group and our group has extensive experience with no adverse events. In the current study MCT will be performed (for the first time) in premature babies born at 30-32 weeks of gestation during 2008-2009 when they reach the age of 3-4 years (2011 and 2012, respectively). The results of MCT of the two groups will be compared.

OTHER

Monthly telephone contact

Monthly telephone contact with the parents/caregivers will be scheduled from enrollment until the final visit at age 3-4 years. Subject illnesses and other medical events occurring during the past month will be recorded at each monthly follow-up.

OTHER

Visits to the study site

Visits to the study site will be conducted at 6-month intervals in which physicians will record intercurrent doctor visits, emergency visits, and hospitalizations for respiratory symptoms.

OTHER

Blood Test

For assessing IgE levels, Eosinophils count and cytokines levels

OTHER

Fractional exhaled nitric oxide

Participant blow tidal volume for determination of exhaled NO in Exhaled breath.

Trial Locations (1)

32000

Rambam Medical Center, Haifa

All Listed Sponsors
lead

Rambam Health Care Campus

OTHER

NCT01269528 - Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation | Biotech Hunter | Biotech Hunter