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Prematurity and Respiratory Outcomes Program (PROP) (PROP)

4 november 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Werkelijk)

835

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

1 dag tot 1 week (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.

Groep / Cohort

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Respiratory morbidity Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Pennsylvania

Medewerkers

National Heart, Lung, and Blood Institute (NHLBI)

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2011

Primaire voltooiing (Werkelijk)

1 april 2015

Studie voltooiing (Werkelijk)

1 maart 2016

Studieregistratiedata

Eerst ingediend

14 september 2011

Eerst ingediend dat voldeed aan de QC-criteria