Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

GER Poses a Potential Risk for Late Complications of BPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03014453
Recruitment Status : Completed
First Posted : January 9, 2017
Results First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Shucheng Zhang, Shengjing Hospital

Brief Summary:
Bronchopulmonary dysplasia (BPD) is a common condition in the low birth weight infants. Although most of the BPD symptoms improved after a regular treatment in infancy, there are still a few late complications left such as the frequent respiratory symptoms, a slower weight gain and even sudden death. These late complications have made so much trouble to the healthcare of BPD infants. How to find the risk factors and to reduce the prevalence of these late symptoms becomes necessary. In this study, a cohort of BPD infants was observed with the late complications obtained by a monthly followed up for 18 months after discharge, the prevalence and risk factors of the late complications of BPD were analyzed by logistic regression. As one of the risk factors, GER was verified whether to play a critical role in these late complications.

Condition or disease
Gastroesophageal Reflux Bronchopulmonary Dysplasia

Layout table for study information
Study Type : Observational
Actual Enrollment : 187 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gastroesophageal Reflux Poses a Potential Risk for Late Complications of BPD: A Prospective Study
Actual Study Start Date : January 9, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : July 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD




Primary Outcome Measures :
  1. the Late Complications of BPD Infants [ Time Frame: 18 months ]
    In all patients, complications were evaluated via questionnaires at 3, 6, 9 and 12 months corrected for premature age, including respiratory symptoms (including home respiratory support, respiratory medication administration, cough without cold at least once per week, re-hospitalization due to respiratory diseases), vomiting when feeding, hypoxic ischemic injury, retinopathy of prematurity, rehospitalization and sudden death.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Extremely Premature Infants with Bronchopulmonary Dysplasia
Criteria

Inclusion Criteria:

  • the extremely premature infants with bronchopulmonary dysplasia

Exclusion Criteria:

  • other congenital malformations such as gastrointestinal and or neurogenic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014453


Locations
Layout table for location information
China, Liaoning
Shengjing Hospital
Shenyang, Liaoning, China, 110004
Sponsors and Collaborators
Shengjing Hospital
  Study Documents (Full-Text)

Documents provided by Shucheng Zhang, Shengjing Hospital:
Informed Consent Form  [PDF] March 24, 2020

Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Shucheng Zhang, Professor, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT03014453    
Other Study ID Numbers: A333-1
First Posted: January 9, 2017    Key Record Dates
Results First Posted: March 26, 2020
Last Update Posted: March 26, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Bronchopulmonary Dysplasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases