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

NCT06123845 | Unknown

• 1 other identifier: 2018//ST/231
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome in Premature Infant

Keywords

RDS; NCPAP; PEEP; lung recruitment; delivery room resuscitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Exhaled tidal volumes (Vte)

  From randomization assessed every minute up to 15 minutes of life

• HR

  From randomization assessed every minute up to 15 minutes of life

• SpO2

  From randomization assessed every minute up to 15 minutes of life

• PPV

  From randomization up to 15 minutes of life

• ET

  From randomization up to 15 minutes of life

Study Arms (2)

CPAP 8

EXPERIMENTAL

Upon arrival of the infant on the neonatal resuscitation trolley, start the normal standard procedures required by international protocols (e.g., drying, temperature control measures, placement of pulse-oximeter sensor to the right hand or wrist, etc.). Immediately start CPAP application with mask and T-piece: the CPAP level will be set at 8 cmH2O. Perform gentle tactile stimulation if the child is not breathing in appropriately. Place the pulse-oximeter sensor on the right hand then connect it to the oxymeter previously turned on. Assess breathing and HR for 30 seconds. Perform the next step of the flow-chart of resuscitation in the delivery room according to the Neonatal Resuscitation Program guidelines. If positive pressure ventilation (PPV) is required (in case of persistent bradycardia or apnea), maintain PEEP at 8 cm H2O and an initial PIP of 25 cm H2O. The CPAP level will be reduced to 6 cm H2O after 15 minutes of life, then the recording will be discontinued.

Behavioral: static CPAP 8 cmH2O

CPAP 5

ACTIVE COMPARATOR

Upon arrival of the infant on the neonatal resuscitation trolley, start the normal standard procedures required by international protocols (e.g., drying, temperature control measures, placement of pulse-oximeter sensor to the right hand or wrist, etc.). Immediately start CPAP application with mask and T-piece: the CPAP level will be set at 5 cmH2O. Perform gentle tactile stimulation if the child is not breathing in appropriately. Place the pulse-oximeter sensor on the right hand then connect it to the oxymeter previously turned on. Assess breathing and HR for 30 seconds. Perform the next step of the flow-chart of resuscitation in the delivery room according to the Neonatal Resuscitation Program guidelines. If positive pressure ventilation (PPV) is required (in case of persistent bradycardia or apnea), maintain PEEP at 5 cm H2O and an initial PIP of 25 cm H2O. The CPAP level will be raised to 6 cm H2O after 15 minutes of life, then the recording will be discontinued.

Behavioral: static CPAP 5 cmH2O

Interventions

static CPAP 8 cmH2O BEHAVIORAL

Set static CPAP or PEEP pressure level at 8 cmH2O

CPAP 8

static CPAP 5 cmH2O BEHAVIORAL

Set static CPAP or PEEP pressure level at 5 cmH2O

CPAP 5

Eligibility Criteria

• Age: 26 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Congenital anomalies

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead

Study Sites (1)

Ospedale dei Bambini Vittore Buzzi

Milan, Lombardy, 20154, Italy

RECRUITING

Central Study Contacts

Francesco Cavigioli, MD

CONTACT

+39263635341; francesco.cavigioli@asst-fbf-sacco.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Sealed opaque envelopes randomization

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 9, 2023
• Study Start: April 11, 2019
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)