pretermn infants with respiratory insufficence with/without BPD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Preterm newborns with a gestational age less than or equal 30 weeks requiring invasive or non-invasive respiratory support.
Exclusion criteria
Exclusion criteria: - Outborn - Presence of major congenital malformations and/or genetic syndromes - Fetal hydrops - Inherited disorders of metabolism - Persistent Pulmonary Hypertension of Newborn - Severe circulatory shock (prolonged capillary filling, reduced strength of peripheral pulses, cool skin, lethargy, hypotension, oliguria, increasing lactate concentrations and metabolic acidosis) - Others unstable clinical conditions at the time of randomization for which the newborn can not perform the physiotherapy treatment required by the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of intubation and mechanical ventilation (MV) in the first week of life (excluding the intubation necessary for surfactant administration). This will represent the primary outcome for non-intubated infants in the delivery room. | — |
Secondary
| Measure | Time frame |
|---|---|
| - duration of MV during the hospital stay (only for the babies not intubated in the delivery room); - duration of O 2 -therapy during the hospital stay; - development of BPD (O 2 -dependence at 36 weeks of postmenstrual age); - incidence of atelectasis, - duration of non-invasive ventilation (NIV) during the hospital stay; - post-conceptional age attainment of complete respiratory autonomy (absence of any kind of respiratory support and oxygen); - length of the hospital stay - survival. | — |
Countries
Europe
Contacts
Foundation P. University A. Gemelli IRCCS Division of Neonatology