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Completed

NCT Number: NCT01269528

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

Protocol Synopsis: There is a link between early RSV infection and chronic respiratory morbidity.

Hypothesis: Palivizumab administration may result in decreased AHR and lower respiratory morbidity.

Primary objective: to evaluate prospectively the effect of palivizumab on airway reactivity (AHR) in children born at 29-32 weeks.

Secondary objective: to assess prospectively the effect of palivizumab on respiratory morbidity airway inflammation and allergy in children born at 29-32 weeks.

Inclusion criteria: premature babies 29-32 weeks of gestation born during 2007 and 2010.

Exclusion criteria: Any mechanical ventilation or chronic diseases, e.g., bronchopulmonary dysplasia (BPD), cystic fibrosis (CF), congenital heart disease, congenital anomalies, known immunodeficiency, or receipt of other RSV investigative vaccines or therapies.

Primary end points: Airway reactivity as assessed by methacholine challenge test with determination of PC20.

Secondary end points: Respiratory morbidity as assessed by questionnaire and telephone interviews. Additionally, IGE, eosinophil count, and exhaled NO will be evaluated.

Sample size: 74 participants; Group I - 37 premature babies at 29-32 weeks of gestation born during 2007-2008 (before approval of Synagis for this group in Israel). Group II - 37 premature babies 29-32 weeks of gestation born during 2009-2010 (after approval of Synagis for this group in Israel).

Statistics: A sample size of 37 patients was calculated as necessary to detect a difference of 0.5 SD in AHR for a 2-sided tail, with a power of 80%. Demographics and baseline characteristics will be compared using 1-way analysis of variance for quantitative variables and Fisher's exact test for categorical variables.

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Key information

Conditions

Bronchial Hyperreactivity Bronchial Diseases Female Urogenital Diseases and Pregnancy Complications Infant, Premature Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rambam Medical Center

Haifa, 32000, Israel

About this study

Protocol Synopsis: There is a link between early RSV infection and chronic respiratory morbidity.

Hypothesis: Palivizumab administration may result in decreased AHR and lower respiratory morbidity.

Primary objective: to evaluate prospectively the effect of palivizumab on airway reactivity (AHR) in children born at 29-32 weeks.

Secondary objective: to assess prospectively the effect of palivizumab on respiratory morbidity airway inflammation and allergy in children born at 29-32 weeks.

Inclusion criteria

premature babies 29-32 weeks of gestation born during 2007 and 2010.

Exclusion criteria

Any mechanical ventilation or chronic diseases, e.g., bronchopulmonary dysplasia (BPD), cystic fibrosis (CF), congenital heart disease, congenital anomalies, known immunodeficiency, or receipt of other RSV investigative vaccines or therapies.

Primary end points: Airway reactivity as assessed by methacholine challenge test with determination of PC20.

Secondary end points: Respiratory morbidity as assessed by questionnaire and telephone interviews. Additionally, IGE, eosinophil count, and exhaled NO will be evaluated.

Sample size: 74 participants; Group I - 37 premature babies at 29-32 weeks of gestation born during 2007-2008 (before approval of Synagis for this group in Israel). Group II - 37 premature babies 29-32 weeks of gestation born during 2009-2010 (after approval of Synagis for this group in Israel).

Statistics: A sample size of 37 patients was calculated as necessary to detect a difference of 0.5 SD in AHR for a 2-sided tail, with a power of 80%. Demographics and baseline characteristics will be compared using 1-way analysis of variance for quantitative variables and Fisher's exact test for categorical variables..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premature babies 29-32 weeks of gestation born during 2007 and 2010

Exclusion criteria

  • Any mechanical ventilation
  • Chronic diseases, e.g., bronchopulmonary dysplasia (BPD), cystic fibrosis (CF), congenital heart disease, congenital anomalies
  • Known immunodeficiency
  • Receipt of other RSV investigative vaccines or therapies

Treatment and study plan

Methacholine Challenge Test (MCT)

Other

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.

Monthly telephone contact

Other

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.

Visits to the study site

Other

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.

Blood Test

Other

For assessing IgE levels, Eosinophils count and cytokines levels

Fractional exhaled nitric oxide

Other

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

Primary outcomes

  1. Airway reactivity

    Time frame: Between the 3 to 4 years-of-age

    As assessed by methacholine challenge test with determination of PC20 and inflammatory mediators in exhaled breath condensate.

Secondary outcomes

  1. Respiratory morbidity

    Time frame: every month

    Monthly telephone contact with the parents/caregivers will be scheduled from enrollement until the final visit at age 3-4 years. Visits to the study site will be conducted at 6-month intervals. Subject illnesses and other medical events occurring during the past month will be recorded at each monthly follow-up. At 6-month intervals, physicians will record intercurrent doctor visits, emergency visits, and hospitalizations for respiratory symptoms.

  2. IgE

    Time frame: Between the 3 to 4 years-of-age

    in pereferal Blood count

  3. Eosinophil count

    Time frame: Between the 3 to 4 years-of-age

    in pereferal Blood count

  4. skin tests for inhaled allergens

    Time frame: Between the 3 to 4 years-of-age

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 4, 2011
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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