Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome

NCT01440868 | Unknown DMC

• 1 other identifier: 02-2011
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND. Sustained lung inflation (SLI) associated to an adequate PEEP may help the efficacy of the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome (RDS) and reduce need of mechanical ventilation (MV). The investigators aim will be to demonstrate the hypothesis that the introduction of SLI in the delivery room protocol may reduce the need of MV in preterm infants. STUDY DESIGN: Multicenter prospective randomized controlled trial. The study will be carried out at the neonatal care units of the Careggi Infants with a gestational age between 25 and 28 weeks will be eligible and randomized at birth to receive SLI or not. Peak inflation pressure (PIP) of 25 cm H2O will be delivered for 15 seconds and then reduced to a positive end expiratory pressure (PEEP) of 5 cm H2O. Primary endpoint will be the need of MV within the first 72 hrs of life (excluding the transient tracheal intubation for surfactant replacement: e.g. INSURE). Population size: hypothesizing that SLI maneuver might decrease the need of MV during the first 72 hours of life from 35 to 20% the investigators calculated that 138 newborns must be enrolled in each groups to detect this difference statistically significant with 80% power at 0.05 level.

Conditions

Respiratory Distress Syndrome

Keywords

Respiratory Distress Syndrome, Newborn; Delivery Rooms; Resuscitation; Premature Birth; Infant, Newborn; Respiration, Artificial

Outcome Measures

Primary Outcomes (1)

• Need of mechanical ventilation

  Preterm infants are at risk of developing respiratory distress syndrome requiring mechanical ventilation. Sustained lung inflation in the delivery room might contribute to decrease the need of mechanical ventilation during the first 72 hrs of life because later other factors (i.e.: sepsis)than prematurity itself could induce this need.

  First 72 hrs of life

Secondary Outcomes (1)

• Complication rate

  Participants will be followed for the duration of hospital stay, an expected average of 13 weeks

Study Arms (2)

SLI group

EXPERIMENTAL

In this group the preterm infants will receive sustained lung inflation (SLI) with mask in the delivery room

Procedure: Sustained lung inflation

Control

NO INTERVENTION

Preterm infants will be assisted in the delivery room without sustained lung inflation.

Interventions

Sustained lung inflation PROCEDURE

Sustained lung inflation (SLI) will be performed with mask using a pressure control system (Neopuff, Fisher \& Paykel, Inc). Peak inflation pressure (PIP) of 25 cm H2O will be delivered for 15 seconds and then reduced to a PEEP of 5 cm H2O. A second SLI manoeuvre will be repeated in case of persistent hearth failure (HR \<100 bpm ).

Also known as: Lung recruitment

SLI group

Eligibility Criteria

• Age: Up to 15 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• parental informed consent
• gestational age 25-28 weeks

You may not qualify if:

• fetal hydrops
• major congenital malformation
• inherited metabolic diseases

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

Department of Surgical and Medical Critical Care, Unversity of Florence

Florence, 50134, Italy

Location

Related Publications (1)

• Dani C, Lista G, Pratesi S, Boni L, Agosti M, Biban P, Del Vecchio A, Gazzolo D, Gizzi C, Magaldi R, Messner H, Mosca F, Sandri F, Scopesi F, Trevisanuto D, Vento G. Sustained lung inflation in the delivery room in preterm infants at high risk of respiratory distress syndrome (SLI STUDY): study protocol for a randomized controlled trial. Trials. 2013 Mar 8;14:67. doi: 10.1186/1745-6215-14-67.

  PMID: 23497495 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Premature Birth; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlo Dani, MD

  University of Florence, Italy

  STUDY CHAIR

Central Study Contacts

Carlo Dani, MD

CONTACT

+39 055 7947428; cdani@unifi.it

Simone Pratesi, MD

CONTACT

+39 055 7947792; simone.pratesi@unifi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: September 16, 2011
• First Posted: September 27, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 27, 2011

Record last verified: 2011-09

Locations

IT (1)