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Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease - The AD-ON Study

Information source: Hillerod Hospital, Denmark
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Term Delivery With Preterm Labor, Third Trimester; Term Delivery With Preterm Labor, Unspecified Trimester; Bronchopulmonary Dysplasia

Intervention: measurements (Procedure)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Hillerod Hospital, Denmark

Official(s) and/or principal investigator(s):
Birgitte J Schmidt, MD, Principal Investigator, Affiliation: ChildrenĀ“s Dep, North Zealand Hospital Hilleroed, Denmark

Summary

Children born prematurely are of greater risk of developing chronic lung disease (Bronchopulmonary Dysplasia). With an increase in the amount of premature children, we expect an increasing number of children with BPD. Today we do not have many ways of predicting or treating this condition, and the children are usually in hospital for several months after birth. Many are dismissed with home oxygen. Children with BPD are typically often re-submitted to hospital with respiratory disease the first couple of years, and some of them have problems throughout childhood and into adulthood. Other scientists have found a correlation between BPD and Chronic Obstructive Pulmonary Disease (COPD). The condition as well as the treatment (steroids), are associated with great risk of adverse effects as Cerebral Palsy, blindness, deafness and mental retardation. The investigators wish to find a safe way to identify the children in greater risk of developing BPD, who could therefore benefit from a more intensive treatment. An early diagnosis would increase the possibility of predicting the prognosis. Other studies have proven a connection between both low vitamin A and D and high exhaled nitrogen oxide (NO) with lung disease. With this trial the investigators wish to make a reference material for NO and vitamins A and D in infants admitted to the neonatal department at two hospitals in Denmark, both with and without treatment with nasal Continuous Positive Airway Pressure. The investigators furthermore wish to describe an eventual connection between BPD and these factors by examining a large group of children on 7 specific occasions within the first two months of life and at a one year follow up.

Clinical Details

Official title: AD-ON: The Danish Study on Tidal Neonatal Nitrogen Oxide (NO) and Vitamins A and D as Possible Predictors of BPD

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Tidal exhaled Nitrogen Oxide

Secondary outcome: Vitamin levels

Eligibility

Minimum age: N/A. Maximum age: 2 Days. Gender(s): Both.

Criteria:

Inclusion Criteria:

Cohort inclusion - All term and preterm infants admitted to Neonatal (Intensive) Care

Unit. Gestational Age 24-42 weeks. Exclusion Criteria: 1. Children with ciliary dyskinesia, as NO is distinguishable lower in these children. 2. Children who can not cooperate to the examination. 3. Children so dependant on oxygen, that the examination/measurement is not possible. 4. Children with pneumothorax 5. Children having a diagnosed pneumonia verified by tracheal secrete. 6. Children with bigger congenital anomalies

Locations and Contacts

Neonatal departement GN, Rigshospitalet, Copenhagen, Region H 2200, Denmark

ChildrenĀ“s Departement, North Zealand Hospital, Hilleroed, Hilleroed, Region H 3400, Denmark

Additional Information

Starting date: August 2013
Last updated: May 29, 2015

Page last updated: August 20, 2015

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