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Prematurity and Respiratory Outcomes Program (PROP) (PROP)

4 novembre 2016 mis à jour par: University of Pennsylvania

Prematurity and Respiratory Outcomes Program (PROP) Core Database Protocol

In survivors of extreme prematurity to 36 weeks Post Menstrual Age (PMA), specific biologic, physiologic and clinical data obtained during the initial hospitalization will predict respiratory morbidity as defined by respiratory health care utilization and respiratory symptoms, between discharge and 1 year corrected age.

This protocol describes a collaboratively developed multicenter study of very preterm infants from birth through the time of discharge from the Neonatal Intensive Care Unit (NICU) and up to 1 year of age, corrected for the degree of prematurity.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

The primary goal of the PROP studies is to identify biomarkers (biochemical, physiological and genetic) and clinical variables that are associated with and thus potentially predictive of pulmonary status in preterm infants up to 1 year corrected age. An objective and validated measure of pulmonary outcome at 1 year does not currently exist. Some promising measures are in development but not yet ready for use in a multi-center large clinical study.

Moreover, the burden of chronic respiratory illness on the infants and their families is of utmost importance. A composite primary outcome of morbidity that is based on serial parental reports of respiratory symptoms, medications, hospitalizations and dependence on technology during the first year of life has been developed.

Data collection for the outcome assessment will be based on interviews conducted with the infant's main caregiver at 3, 6, 9 and 12 months corrected age. The time frame for data collection is based on questions "since last contact." Numerous epidemiological studies of asthma have used parental or self report of symptoms, physician-diagnosed asthma and allergies, or the use of medications (which may abrogate symptoms) as critical outcomes.

Survey items selected for the determination of the primary outcome will be focused on the following four domains, with any positive response to any element identifying morbidity:

Respiratory medications: inhaled bronchodilators, inhaled steroids, systemic steroids, methylxanthines, diuretics, pulmonary vasodilators
Hospitalizations for cardiopulmonary causes: any hospitalization regardless of duration
Symptoms: any wheeze, cough without cold
Home technology dependence: use of home oxygen, ventilator or continuous positive airway pressure (CPAP or BiPAP) of any duration since last contact

The primary outcome will be dichotomous, and defined as "No substantial post-prematurity respiratory disease" or "Post-prematurity respiratory disease." To be classified as having post-prematurity respiratory disease, infants must have a positive response in at least 1 of 4 morbidity domains during at least 2 separate parental interviews. Quarterly data collection up to 1 year corrected age will allow us to identify phenotypes based on the trajectory of post-prematurity respiratory disease and how these different trajectories predict later lung function and the diagnosis of asthma, if we continue to follow this cohort of children.

During hospitalization, all centers will obtain samples of tracheal aspirate, urine and saliva (for DNA extraction) from enrolled infants. At 36 weeks PMA, infants will have respiratory assessments dependent upon their respiratory status: i) respiratory inductive plethysmography (RIP) assesses alterations in tidal breathing resulting from reduced lung compliance and airway obstruction, ii) and a room air challenge (RAC).

Type d'étude

Observationnel

Inscription (Réel)

835

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

États-Unis
- California
  - Oakland, California, États-Unis, 94609
    - Alta Bates Summit Medical Center
  - San Francisco, California, États-Unis, 94143
    - University of California, San Francisco
- Indiana
  - Indianapolis, Indiana, États-Unis, 46202
    - Indiana University Health/Riley Hospital for Children
- Missouri
  - St Louis, Missouri, États-Unis, 63130
    - Washington Universitiy
- New York
  - Buffalo, New York, États-Unis, 14260
    - University of Buffalo
  - Rochester, New York, États-Unis, 14642
    - University of Rochester
- North Carolina
  - Durham, North Carolina, États-Unis, 27710
    - Duke University Medical Center
- Ohio
  - Cincinnati, Ohio, États-Unis, 45229
    - Cincinnati Children's Hospital
  - Cincinnati, Ohio, États-Unis, 45220
    - Good Samaritan Hospital
  - Cincinnati, Ohio, États-Unis, 45219
    - Cincinnati University Hospital
- Tennessee
  - Jackson, Tennessee, États-Unis, 38301
    - Jackson-Madison County General Hospital
  - Nashville, Tennessee, États-Unis, 37232
    - Monroe Carell Jr Children's Hospital at Vanderbilt
- Texas
  - Houston, Texas, États-Unis, 77030
    - University of Texas, Houston

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

1 jour à 1 semaine (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Infants admitted to the Neonatal Intensive Care Unit who are < 29 weeks gestational age

La description

Inclusion Criteria:

Infants who are less than or equal to 7 days old
Gestational Age (GA) between 23 weeks and 0/7 days and 28 weeks and 6/7 days

Exclusion Criteria:

Infants who meet any of the following conditions will be excluded from the PROP cohort:
1. The infant is not considered to be viable (decision made not to provide life-saving therapies)
2. Congenital heart disease (not including PDA and hemodynamically insignificant VSD or ASD)
3. Structural abnormalities of the upper airway, lungs or chest wall
4. Other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development
5. Family is unlikely to be available for long-term follow-up

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
Infant Pulmonary Function Testing (iPFT) A standardized method of performing infant PFTs using the raised volume rapid thoracoabdominal compression (RVRTC) technique will be used. This test will be performed on infants at one year (corrected age). The target sample size of 180 studies will represent the largest number of RVRTC PFTs in the preterm population and will enhance study of the relationship between lung function at 1 year of age and clinical and biologic factors associated with respiratory disease. Although the primary PFT measures will be derived from RVRTC, V'maxFRC, respiratory system compliance (Crs) and resistance (Rrs) will also be measured because these can be easily obtained. Crs and Rrs will be obtained using the single breath occlusion method.

Groupe / Cohorte

Infant Pulmonary Function Testing (iPFT)

A standardized method of performing infant PFTs using the raised volume rapid thoracoabdominal compression (RVRTC) technique will be used. This test will be performed on infants at one year (corrected age). The target sample size of 180 studies will represent the largest number of RVRTC PFTs in the preterm population and will enhance study of the relationship between lung function at 1 year of age and clinical and biologic factors associated with respiratory disease. Although the primary PFT measures will be derived from RVRTC, V'maxFRC, respiratory system compliance (Crs) and resistance (Rrs) will also be measured because these can be easily obtained. Crs and Rrs will be obtained using the single breath occlusion method.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Respiratory morbidity Délai: 1 year (corrected age)	The primary goal of the PROP studies (single center and multicenter protocols) is to identify biomarkers (biochemical, physiological and genetic) and clinical variables that are associated with and thus potentially predictive of pulmonary status in preterm infants up to 1 year corrected age.	1 year (corrected age)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Pennsylvania

Collaborateurs

National Heart, Lung, and Blood Institute (NHLBI)

Les enquêteurs

Chercheur principal: Barbara K Schmidt, MD, University of Pennsylvania
Chercheur principal: Jonas H Ellenberg, PhD, University of Pennsylvania
Chercheur principal: Gloria S Pryhuber, MD, University of Rochester
Chercheur principal: Alan H Jobe, MD, PhD, Cincinnati Childrens Hospital
Chercheur principal: Aaron Hamvas, MD, Washington University School of Medicine / St. Louis Children's Hospital
Chercheur principal: Judy Aschner, MD, Vanderbilt University School of Medicine
Chercheur principal: Roberta L Keller, MD, University of California San Francisco/Benioff Children's Hospital
Chercheur principal: Judith Voynow, MD, Duke University
Chercheur principal: Stephanie D Davis, MD, Indiana University/Riley Hospital for Children

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 août 2011

Achèvement primaire (Réel)

1 avril 2015

Achèvement de l'étude (Réel)

1 mars 2016

Dates d'inscription aux études

Première soumission

14 septembre 2011

Première soumission répondant aux critères de contrôle qualité