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

NCT01722760 | Completed DMC

• 1 other identifier: H-4-2012-091
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Term Delivery With Preterm Labor, Third Trimester; Term Delivery With Preterm Labor, Unspecified Trimester; Bronchopulmonary Dysplasia

Keywords

Neonatal; Preterm; Bronchopulmonary Dysplasia; Nasal Continuous Positive airway Pressure (CPAP); Oxygen; Vitamin A; Vitamin D; Nitrogen oxide (NO); Reference material

Outcome Measures

Primary Outcomes (1)

• Tidal exhaled Nitrogen Oxide

  Reference material of tidal expiratory NO in a cohort of neonates admitted to Neonatal Intensive Care Unit and Neonatal Care Unit will be made. All children in the study will be measured on 8 occasions including a one year follow up. Association with Bronchopulmonary Dysplasia (BPD) and the measures above will be noted.

  6-7 measures within the first 2 months of life and at 1 year of age.

Secondary Outcomes (1)

• Vitamin levels

  From birth to a one year follow up

Other Outcomes (1)

• Bronchopulmonary Dysplasia

  From premature birth to a one year follow up

Study Arms (1)

Term and preterm infants

Term and preterm infants

Procedure: measurements

Interventions

measurements PROCEDURE

Term and preterm infants

Eligibility Criteria

• Age: Up to 2 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Term and preterm infants admitted to Neonatal Care Unit for reference material as control group. Preterm infants admitted to Neonatal Intensive Care Unit developing BPD as study group.

You may not qualify if:

• Children with ciliary dyskinesia, as NO is distinguishable lower in these children.
• Children who can not cooperate to the examination.
• Children so dependant on oxygen, that the examination/measurement is not possible.
• Children with pneumothorax
• Children having a diagnosed pneumonia verified by tracheal secrete.
• Children with bigger congenital anomalies

Sponsors & Collaborators

• Hillerod Hospital, Denmark: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (2)

Neonatal departement GN, Rigshospitalet

Copenhagen, Region H, 2200, Denmark

Location

Children´s Departement, North Zealand Hospital, Hilleroed

Hilleroed, Region H, 3400, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Air samples for Nitrogen oxide NO. Maternal, cord and neonatal blood samples for vitamins A and D.

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Birgitte J Schmidt, MD

  Children´s Dep, North Zealand Hospital Hilleroed, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: November 7, 2012
• Study Start: August 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 6, 2015

Record last verified: 2015-11

Locations

DK (2)