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Prematurity and Respiratory Outcomes Program (PROP) (PROP)

4. november 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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:

  1. Respiratory medications: inhaled bronchodilators, inhaled steroids, systemic steroids, methylxanthines, diuretics, pulmonary vasodilators
  2. Hospitalizations for cardiopulmonary causes: any hospitalization regardless of duration
  3. Symptoms: any wheeze, cough without cold
  4. 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).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

835

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 dag til 1 uge (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pennsylvania

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2011

Primær færdiggørelse (Faktiske)

1. april 2015

Studieafslutning (Faktiske)

1. marts 2016

Datoer for studieregistrering

Først indsendt

14. september 2011

Først indsendt, der opfyldte QC-kriterier

14. september 2011

Først opslået (Skøn)

16. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. november 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 813839
  • U01HL101794-02 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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