PulmonaRy Inflammation and glucocorticoiD sensItivity for the prediCTion of BronchoPulmonary Dysplasia (PRIDICT-BPD): a feasibility study.

Preterm infants who develop bronchopulmonary dysplasia (BPD) are at high risk
of cognitive impairments and cerebral palsy. The adrenal cortex of extremely
preterm infants is immature, resulting in a cortisol level that is too low for
the degree of illness. Novel data suggest that not only the production but also
the action of cortisol is impaired in this group. Prophylactic treatment with
systemic corticosteroids is effective for the prevention of BPD, but increases
the risk of adverse neurodevelopment.

It is generally assumed that infants at high risk of BPD may benefit from
prophylactic corticosteroids, whereas in low-risk infants the adverse effects
of this treatment probably outweigh the beneficial effects. However, clinical
prediction models for BPD lack accuracy.

We propose a novel strategy for the prediction of BPD that includes assessment
of (1) adrenocortical output, (2) single-nucleotide polymorphisms (SNPs) in
corticosteroid-responsive genes expressed during lung development, and (3)
pulmonary inflammation.

Therefore we will collect material post partum to test above assays. First cord
blood and placental tissue will be collected after delivery. During admission
on the neonatology intensive care unit whole blood and exhaled breath will be
collected four times.

The objective of this study is to test whether the assays described above are
feasible to predict bronchopulmonary dysplasia in premature infants.

Prospectie follow-up study during the initial hospital admission.

Improving outcomes in the growing population of extremely preterm infants is
one of the major challenges in neonatal care today. There are no burdens or
risks associated with participation in this study. Cord blood will be collected
after clamping the cord. And biopsy of placental material will take place after
delivery. So for both procedures no adverse effects will be expected. Blood
(cumulative amount: 2 ml over a 28 day period) 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.
Exhaled breath will be collected without loss of positive and expiratory
pressure or respiratory support. Therefore, no additional risk is associated
with this procedure.

Furthermore, the decision to start treatment with corticosteroids will remain
at the discretion of the treating physician and will not be based on the assays
being tested.