Proper Pressure and Duration of Sustained Lung Inflation in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The appropriate pressure and duration needed for sustained lung inflation in preterm infants at risk of respiratory distress syndrome have not been well evaluated. We aim for evaluating two different pressures, 20 and 15 cm H2O, for two different duration, 10 and 20 seconds, during the application of sustained lung inflation in the resuscitation of preterm infants with respiratory distress in the delivery room.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sustained Lung Inflation in Preterm Infants

NCT03518762

Preterm Infant

COMPLETED NA

Ventilatory Management of the Preterm Neonate in the Delivery Room

NCT01255826

Respiratory Distress Syndrome, Newborn

COMPLETED PHASE2

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

NCT01440868

Respiratory Distress Syndrome

UNKNOWN NA

Vojta Reflex Versus Lung Squeezing Technique in Respiratory Distress Preterm Neonate

NCT06992492

Respiratory Distress Syndrome

COMPLETED NA

Effect of Implementing Evidence Based Practices on Prevention of Associated Nasal Pressure Injuries Among Preterm Neonates With Non-Invasive Respiratory Support

NCT06642285

Mechanical Ventilation Complication Respiratory Distress Syndrome in Premature Infant

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will be a randomized prospective pilot study in Mansoura University Hospital then the cases were followed at Neonatal Intensive Care Unit in Mansoura University Children Hospital, Mansoura, Egypt.

Preterm infants born equal to or less than 32 weeks gestation with respiratory distress syndrome will be included in the study.

We aim to study the proper pressure and duration of sustained lung inflation in the delivery room.

Preterm infants will be divided into 5 groups:

1. Group 1 (Control group). In this group preterm infants will not be treated with sustained lung inflation and in stead will receive regular respiratory care
2. Group 2 (High pressure for long duration group). Preterm infants in this group will be treated with sustained lung inflation at pressure of 20 cm H2O for 20 seconds
3. Group 3 (High pressure for short duration group). Preterm infants in this group will be treated with sustained lung inflation at pressure of 20 cm H2O for 10 seconds.
4. Group 4 (Low pressure for long duration group). Preterm infants in this group will be treated with sustained lung inflation at pressure of 15 cm H2O for 20 seconds.
5. Group 5 (Low pressure for short duration group). Preterm infants in this group will be treated with sustained lung inflation at pressure of 15 cm H2O for 10 seconds

Sustained lung inflation will be delivered using the T - piece ventilator (Neopuff infant resuscitator; Fisher \& Paykel, Auckland, New Zealand ).

All preterm infants with respiratory distress will follow the following steps for neonatal resuscitation

1. All infants will receive initial care including providing warmth, clearing the airway, and drying and stimulating the infant.
2. After the initial steps, pulse oximetry will be initiated to determine oxygen saturation and to guide the required FIO2.
3. Infants in the intervention groups will receive a single single maneuver of sustained lung inflation with the first breath according to the study group.
4. Continuous positive airway pressure at a pressure of 5 cm H2O and FIO2 of 30% will be delivered to infants in the control group immediately after initial steps of resuscitation and to all infants in the intervention groups after the single maneuver of sustained lung inflation.
5. Positive pressure ventilation will be provided uring the T-piece resuscitator if the infant has an inadequate respiratory effort or a heart rate \<100 beats per minute at a rate of 40 to 60 times per minute for 30 seconds, after which the heart rate is measured.
6. Oxygen therapy will be titrated to keep a pre-ductal saturation between 90-95%.
7. Endotracheal intubation will be provided if positive pressure ventilation is ineffective, prolonged apnea, or chest compression is required.
8. Chest compression will be required if the infant's heart rate remains \<60 bpm despite adequate ventilation for 30 seconds.
9. Surfactant will be administered to preterm infants requiring a fraction of inspired oxygen of 40 percent or higher to maintain oxygen saturation above 90 percent or remain apneic.
10. Mechanical ventilation will be initiated for preterm infants with respiratory acidosis documented by an arterial pH \<7.2 and PaCO2 \>60 to 65 mmHg, hypoxia documented by an arterial PaO2 \<50 mmHg despite FiO2 exceeds 40 percent on nasal continuous positive airway pressure, or severe apnea.

The primary outcome of the study will be the need for endotracheal intubation in the delivery room.

Secondary outcomes include the need for surfactant therapy, the need for endotracheal intubation and mechanical ventilation within 72 hours of birth, the duration of mechanical ventilation and oxygen support, development of air leak syndromes, length of hospital stay, bronchopulmonary dysplasia, necrotising enterocolitis, intraventricular haemorrhage, retinopathy of prematurity, and neonatal mortality before hospital discharge,.

Broncho alveolar lavage will be performed to endotracheally intubated infants enrolled in this study to measure the level of IL-10 as a lung inflammatory marker immediately after birth (basal) then 12 hours after birth (follow up).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Distress Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Infants in this group will not receive sustained lung inflation in the delivery room and will be put immediately on CPAP at a pressure of 5 cm H2O.

Group Type NO_INTERVENTION

No interventions assigned to this group

High pressure for long duration

Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 20 cm H2O for a duration of 20 second for a single intervention followed by CPAP at a pressure of 5 cm H2O.

Group Type ACTIVE_COMPARATOR