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Prematurity and Respiratory Outcomes Program (PROP) (PROP)

4. november 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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).

Studietype

Observasjonsmessig

Registrering (Faktiske)

835

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 dag til 1 uke (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Gruppe / Kohort

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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Respiratory morbidity Tidsramme: 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)

Samarbeidspartnere og etterforskere

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Sponsor

University of Pennsylvania

Samarbeidspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2011

Primær fullføring (Faktiske)

1. april 2015

Studiet fullført (Faktiske)

1. mars 2016

Datoer for studieregistrering

Først innsendt

14. september 2011

Først innsendt som oppfylte QC-kriteriene