Tidal Neonatal NO - is Bronchopulmonary Dysplasia Predictable?

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Hillerod Hospital, Denmark
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Birgitte Johanne Schmidt, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT01722760
First received: October 24, 2012
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Term Delivery With Preterm Labor, Third Trimester
Term Delivery With Preterm Labor, Unspecified Trimester
Bronchopulmonary Dysplasia
Procedure: measurements

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tidal Nitrogen-oxide Levels in Prematurely Born Children With and Without Continuous Positive Airway Pressure - Is Bronchopulmonary Dysplasia Predictable?

Resource links provided by NLM:


Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Tidal exhaled Nitrogen Oxide [ Time Frame: 6-7 measures within the first 2 months of life and at 1 year of age. ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Vitamin levels [ Time Frame: From birth to a one year follow up ] [ Designated as safety issue: No ]

    Blood levels of Vitamins A (s-retinol) and D (se-25(OH)D2 and D3) will be measured at 3 preset occasions and at one year follow up, as well as maternal and cord blood at the time of birth.

    Reference material will be made and association to BPD will be noted.



Other Outcome Measures:
  • Bronchopulmonary Dysplasia [ Time Frame: From premature birth to a one year follow up ] [ Designated as safety issue: No ]
    The incidence of BPD and the correlation the the above mentioned biomarkers.


Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 200
Study Start Date: August 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Term and preterm infants
Term and preterm infants
Procedure: measurements

  Eligibility

Ages Eligible for Study:   up to 2 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01722760

Contacts
Contact: B J Schmidt, M.D +45 48294962 Birgitte.Johanne.Schmidt@regionh.dk
Contact: I M Joergensen, Ass. proff. +045 4829 4308 Merete.Joergensen.01@regionh.dk

Locations
Denmark
Neonatal departement GN, Rigshospitalet Not yet recruiting
Copenhagen, Region H, Denmark, 2200
Contact: Birgitte J Schmidt, MD    + 48294962    Birgitte.Johanne.Schmidt@regionh.dk   
Contact: Gorm Greisen, Professor    +045 3545 4320    Gorm.Greisen@regionh.dk   
Principal Investigator: Birgitte J Schmidt, MD         
Children´s Departement, North Zealand Hospital, Hilleroed Recruiting
Hilleroed, Region H, Denmark, 3400
Contact: Birgitte J Schmidt, Ph.D. -student    +45 48294962    Birgitte.Johanne.Schmidt@regionh.dk   
Contact: Inger M Joergensen, Ass proff.    +45 4829 4308    Merete.Joergensen.01@regionh.dk   
Principal Investigator: Birgitte J Schmidt, MD         
Sponsors and Collaborators
Hillerod Hospital, Denmark
Rigshospitalet, Denmark
Investigators
Principal Investigator: Birgitte J Schmidt, MD Children´s Dep, North Zealand Hospital Hilleroed, Denmark
  More Information

No publications provided

Responsible Party: Birgitte Johanne Schmidt, MD, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01722760     History of Changes
Other Study ID Numbers: H-4-2012-091
Study First Received: October 24, 2012
Last Updated: August 19, 2013
Health Authority: Denmark: National Board of Health

Keywords provided by Hillerod Hospital, Denmark:
Neonatal
Preterm
Bronchopulmonary Dysplasia
Nasal Continuous Positive airway Pressure (CPAP)
Oxygen
Vitamin A
Vitamin D
Nitrogen oxide (NO)
Reference material

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Obstetric Labor, Premature
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Obstetric Labor Complications
Pregnancy Complications
Respiratory Tract Diseases
Ventilator-Induced Lung Injury

ClinicalTrials.gov processed this record on October 23, 2014