To develop a prediction model for BPD using a range of multimodal predictors assessed in the first two weeks of life.
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary parameters:
1. Pulmonary inflammation, as assessed from volatile organic compounds (VOCs);
2. Adrenocortical output, as assessed from levels of cortisol, 17-OH
progesterone and 11-deoxycortisol;
3. Glucocorticoid tissue-sensitivity, as assessed from single-nucleotide
polymorphisms (SNPs) in the glucocorticoid receptor gene and
glucocorticoid-responsive genes involved in lung development.
Primary outcome:
The occurrence and severity of BPD.
Secondary outcome
Secondary outcome:
Neurocognitive development at 1 and 2 years of corrected age, as assessed from
eye tracking at the age (if available in participating center) and the Bayley
Scales of Infant Development, respectively.
Background summary
Extremely preterm infants (<30 weeks of gestation) who develop bronchopulmonary
dysplasia (BPD) are at high risk of serious neurodevelopmental problems.
Pulmonary inflammation is a key factor in the development of BPD. The
adrenal-cortex hormone cortisol is known for its anti-inflammatory effects. In
the first weeks of life preterm infants are unable to produce sufficient
cortisol for the degree of inflammation, and due to the relative abundance of
the precursor steroids 11-deoxycortisol and 17-OH progesterone, their tissues
are relatively resistant to cortisol.
Both can result in insufficient damping of pulmonary inflammation. Prophylactic
treatment with systemic corticosteroids is effective for the prevention of BPD,
but has been associated with an increased risk of adverse neurocognitive
development particularly among infants at low risk of BPD.
These findings warrant a more personal approach in corticosteroid treatment,
targeted at high-risk infants. However, implementation of targeted treatment is
held back by the poor performance of the available prognostic models for BPD
development.
We propose a novel approach for the early identification of infant at risk of
BPD by focusing on 3 major players in the development of BPD, namely 1.
Pulmonary inflammation; 2. Adrenocortical output; and 3. Glucocorticoid
tissue-sensitivity.
With these factors we aim to develop a prediction model for BPD using a
multimodal predictors assessed in the first two weeks of life.
Study objective
To develop a prediction model for BPD using a range of multimodal predictors
assessed in the first two weeks of life.
Study design
Multicenter prospective cohort study.
Study burden and risks
Improving outcomes in the growing population of preterm infants is one of the
major challenges in neonatal care today. There are no burdens or risks
associated with participation in this study. Blood will always be drawn at the
same time as for routine clinical care, so that no additional vena puncture or
heel stick procedures are required for this study. Furthermore, the decision to
start treatment with corticosteroids will remain at the discretion of the
treating physician. This study is specifically focused on infants born <30
weeks of gestation. Such infants have a very high risk of developing BPD, and
generally have a poor prognosis in terms of survival and long-term outcome.
Improving their prognosis is of the utmost importance.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Inclusion criteria
Newborn infant born <30 weeks of gestation
Exclusion criteria
Major congenital anomalies, such as congenital heart and pulmonary defects, and
major genetic anomalies.
Major surgery in the first 24 hours after birth
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76476.029.21 |