Clinical trial NCT06123845: Pressure HIgh or LOw DElivered to Preterm Newborns in the Delivery ROOM
Official title: Pressure HIgh or LOw DElivered to Preterm Newborns in the Delivery ROOM
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Distress Syndrome in Premature Infant
Keywords: RDS
NCPAP
PEEP
lung recruitment
delivery room resuscitation
Lead sponsor: ASST Fatebenefratelli Sacco
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 56
Sex: ALL
Minimum age (years): 26
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sealed opaque envelopes randomization
Primary purpose: TREATMENT

Brief summary: The aim of this randomized pilot clinical trial of preterm infants requiring noninvasive respiratory support for respiratory distress syndrome (RDS) at birth is to improve short-term respiratory outcomes. The main question it aims to answer is:

* Can a CPAP (or a PEEP if ventilation is needed) administered with a face mask and a T-piece at a level of 8 cmH2O improve lung recruitment in the delivery room when compared to administration of a level of 5 cmH2O in a control group?
* Secondly, can improved lung recruitment in the first few minutes of life provide long-term benefits to the premature infant? The participants will be premature infants between 26 and 29+6 weeks gestational age.

Detailed description: BACKGROUND:

It has been widely demonstrated that noninvasive respiratory support (NIV) used in the delivery room can reduce the incidence of pulmonary bronchodysplasia (BPD) and death in very preterm infants weighting less than 1500 g.

In this population, the use of CPAP immediately after birth during the respiratory stabilization in the delivery room has been shown to promote respiratory transition and promote the achievement of an initial adequate functional residual capacity (CFR).

To date, various forms of delivery of additional pressures in the first minutes of life are being studied such as positive pressure ventilation (PPV), sustained inflation (SI), ventilation with dynamic increasing and decreasing levels of CPAP. However, there is no consensus on which pressure is the best and safest to apply and its optimal duration.

This monocentric pilot study aims to verify in preterm infants (26-29+6 weeks EG) the feasibility, efficacy and safety of using two different levels of CPAP (5 vs 8 cmH2O - both of which are contemplated in international guidelines for the management of the premature infant) in the delivery room; it will also test the accuracy and usefulness of the data that can be recorded with an RFM as indices of oxygenation, spontaneous ventilation and therefore of early lung recruitment. The investigators hypothesize that a higher CPAP level (8 cmH2O) for the first 15 minutes of life may lead to faster and more effective lung recruitment.

Statistical calculation The investigators use, as an index of early lung recruitment and as the primary outcome of the study, the SpO2/FiO2 (S/F) ratio as reported in the literature. The investigators calculated that the mean of this value at the end of the early phase of lung recruitment in the delivery room, in an historical local population of premature infants is 271+/-140. Wanting to improve this ratio, and thinking that it is possible to bring it to an average value of 316, (this goal can be achieved by reducing the need for Oxygen in the DR by about 0.05), it was calculated that with alpha=0.05 and beta=0.20 (study power of 80%), the number of patients to be enrolled is equal to 152 infants for each of the two main arms of the study. Given the large size of the sample, for which the involvement of numerous Level III neonatology centers, the investigators considered appropriate to undertake a pilot study to verify its feasibility, enrollment time, costs and moreover to assess and verify proper monitoring with a respiratory Function Monitor (RFM) and the possibility to improve the assessment of primary and secondary outcomes in the final large-scale designed study. To calculate the sample size of the pilot study, the investigators applied the method of calculation described and published by Cocks T. et al in 2013, considering an upper confidence limit of 90%. It was calculated an enrollment of a total of 56 infants (18% of the main study's sample size), or 28 infants for each of the two arms of the study.

In the investigator's Neonatologic Center a maximum of 20 patients per year could realistically be enrolled. It was therefore necessary to involve other centers in this study that had equally the ability and experience in using this equipments in the delivery room. A Neonatal Intensive Care Unit in Canada, which had initially given willingness to participate in the study was later on stopped because of the occurrence of the covid pandemic. Other centers may be involved at a later date for the main study.

Eligibility criteria: Inclusion Criteria:

* Preterm infants at birth between 26 and 29+6 weeks gestational age with Respiratory distress syndrome requiring non invasive respiratory support

Exclusion Criteria:

* Congenital anomalies

Primary outcomes:
measure: Oxygen saturation/Inspired Oxygen fraction (SpO2/FiO2)
timeFrame: From randomization assessed every minute up to 15 minutes of life
Secondary outcomes:
measure: Exhaled tidal volumes (Vte)
timeFrame: From randomization assessed every minute up to 15 minutes of life
measure: HR
timeFrame: From randomization assessed every minute up to 15 minutes of life
measure: SpO2
timeFrame: From randomization assessed every minute up to 15 minutes of life
measure: PPV
timeFrame: From randomization up to 15 minutes of life
measure: ET
timeFrame: From randomization up to 15 minutes of life
measure: MV
timeFrame: From randomization up to 72 hours of life
measure: Surf
timeFrame: From randomization up to 72 hours of life
measure: PNX
timeFrame: From randomization up to 72 hours of life
measure: PIE
timeFrame: From randomization up to 72 hours of life
measure: IVH
timeFrame: From randomization up to 72 hours of life
measure: BPD
timeFrame: assessed at 36 weeks gestational age (GA)
measure: Death
timeFrame: From date of randomization until the date of death from any cause, assessed up to 40 weeks gestational age (GA)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale dei Bambini Vittore Buzzi
state: Lombardy
Study officials:
References: