Pressure HIgh or LOw DElivered to Preterm Newborns in the Delivery ROOM

Respiratory Distress Syndrome in Premature Infant Clinical Trial

— PHILODENDROOM  

Official title:

Pressure HIgh or LOw DElivered to Preterm Newborns in the Delivery ROOM

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06123845
• Other study ID #: 2018//ST/231
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2019
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: ASST Fatebenefratelli Sacco
• Contact: Francesco Cavigioli, MD
• Phone: +39263635341
• Email: francesco.cavigioli[@]asst-fbf-sacco.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Weeks to 30 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome in Premature Infant
• Respiratory Distress Syndrome, Newborn

Intervention

Behavioral:
• static CPAP 8 cmH2O
Set static CPAP or PEEP pressure level at 8 cmH2O
• static CPAP 5 cmH2O
Set static CPAP or PEEP pressure level at 5 cmH2O

Locations

Country	Name	City	State
Italy	Ospedale dei Bambini Vittore Buzzi	Milano	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
ASST Fatebenefratelli Sacco

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen saturation/Inspired Oxygen fraction (SpO2/FiO2)	Oxygen saturation / Inspired Oxygen fraction ratio	From randomization assessed every minute up to 15 minutes of life
Secondary	Exhaled tidal volumes (Vte)	Exhaled tidal volumes	From randomization assessed every minute up to 15 minutes of life
Secondary	HR	Heart rate	From randomization assessed every minute up to 15 minutes of life
Secondary	SpO2	Oxygen peripheral saturation	From randomization assessed every minute up to 15 minutes of life
Secondary	PPV	Need for positive pressure ventilation	From randomization up to 15 minutes of life
Secondary	ET	occurrence of Endotracheal intubation in the delivery room	From randomization up to 15 minutes of life
Secondary	MV	Need for Mechanical ventilation	From randomization up to 72 hours of life
Secondary	Surf	Need for Surfactant administration	From randomization up to 72 hours of life
Secondary	PNX	occurrence of Pneumothorax	From randomization up to 72 hours of life
Secondary	PIE	occurrence of Pulmonary interstitial emphysema	From randomization up to 72 hours of life
Secondary	IVH	occurrence of Intraventricular hemorrhage any grade of severity	From randomization up to 72 hours of life
Secondary	BPD	Clinical diagnosis of Bronchopulmonary dysplasia	assessed at 36 weeks gestational age (GA)
Secondary	Death	Mortality for any cause	From date of randomization until the date of death from any cause, assessed up to 40 weeks gestational age (GA)