The Baby Lung Study
Condition: Bronchopulmonary Dysplasia; Neonatal Disease
MeSH terms: Bronchopulmonary Dysplasia; Infant, Newborn, Diseases
Study type: Observational

Summary: 
      The introduction of exogenous surfactant therapy has significantly improved the mortality in
      preterm infants born between 23- and 28-weeks of gestation. However, the therapy has not
      affected the prevalence of sequelae such as bronchopulmonary dysplasia [BPD] and it may be
      argued that it has actually increased. BPD is a lung condition that affects up to 40% of
      premature babies born between 23 and 28 weeks gestational age. The prevalence of BPD
      decreases with increasing gestational age but can affect infants born at term who have
      required mechanical ventilation. It is most commonly defined based on the need for oxygen
      past 36 weeks post-menstrual age [PMA]. The pathogenesis of BPD is multifactorial and
      involves a complex balance between the underdeveloped lungs, infection, inflammation, oxygen
      toxicity and ventilator induced injury.

      In this study the investigators aim to develop a greater understanding of the interactions
      between the inflammatory markers present in endotracheal aspirates [ETA] and serum of preterm
      infants and surfactant components (including surfactant protein D-SP-D levels) in the lungs
      and in the serum of preterm ventilated infants.

      The investigators aim to recruit infants born between 23+0 and 29+6 weeks of gestation at
      University College London Hospital admitted to the neonatal unit, who are at risk of
      developing respiratory distress syndrome [RDS] and progression to BPD. The investigators plan
      to study the correlation between the concentrations of surfactant components (in particular
      SP-D) and inflammatory markers in infants across the range of gestations specified. In order
      to do this, the investigators will obtain gastric aspirates, endotracheal aspirates [ETA] and
      blood samples at birth, 24hrs and days 2 through to day 7 from participants. ETA will only be
      obtained if the infants are intubated and ventilated, collected by a standard technique
      routinely used in nursing care of ventilated babies using 1-2mls of saline.ETA and blood
      samples will then be analysed for levels of surfactant proteins in particular SP-D and
      inflammatory and immunological markers [cell counts of neutrophils, macrophages, MMPs,
      neutrophil elastase, IL-8, IL-6, IL 11 and IL-1]. This will allow us to map the influence of
      SP-D on pro and anti-inflammatory markers that have a role in the inflammatory component of
      BPD in these infants.

      Clinical data will also be collected at specified time points correlating with the plasma,
      gastric aspirates and endotracheal aspirates. The investigators aim to correlate clinical
      ventilatory parameters, infection factors and maternal factors with the inflammatory and
      surfactant protein profiles. In addition, the investigators will apply the international
      neonatal consortium Neonatal Adverse severity scores to gain a better understanding of the
      baseline incidence of adverse events in premature infants that are admitted to a neonatal
      unit.
    


Intervention name(s): Observational study
Intervention type(s): Other
Intervention description(s): This is an observational study and no additional interventions will be done except for those that are standard care. Blood and tracheal aspirates will be taken to assess the surfactant protein levels and inflammatory markers including cell counts and cytokine levels.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm infants born between 23 + 0 weeks post menstrual age and 30 weeks post menstrual
        age.