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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.
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:
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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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. | |
| High pressure for long duration | Active Comparator | 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. |
|
| High pressure for short duration | Active Comparator | Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 20 cm H2O for a duration of 10 second for a single intervention followed by CPAP at a pressure of 5 cm H2O. |
|
| Low pressure for long duration | Active Comparator | Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 15 cm H2O for a duration of 20 second for a single intervention followed by CPAP at a pressure of 5 cm H2O. |
|
| Low pressure for short duration | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sustained lung inflation in preterms (SLI). | Procedure | Providing a positive pulmonary ventilation with an opening lung pressure for the first breath of preterm infant for a sustained period of time |
| Measure | Description | Time Frame |
|---|---|---|
| The need for endotracheal intubation in the delivery room | One hour |
| Measure | Description | Time Frame |
|---|---|---|
| The need for mechanical ventilation | 72 hours | |
| Need of surfactant | 72 hours | |
| Neonatal mortality |
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Inclusion Criteria:
Preterm infants with gestational age ≤ 32 weeks' gestation, presented with respiratory distress syndrome at birth
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Children Hospital | Al Mansurah | El Dakahlya | 35111 | Egypt |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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Infants in this group will receive sustained lung inflation in the delivery room at a pressure of 15 cm H2O for a duration of 10 second for a single intervention followed by CPAP at a pressure of 5 cm H2O.
|
Death before hospital discharge
| 90 days |
| Broncho Pulmonary Dysplasia ( BPD ) | Requirement for oxygen therapy more than 30% by 36 weeks corrected gestational age | 90 days |
| Intra-Ventricular Hemorrhage ( IVH ) | 14 days |
| Retinopathy of Prematurity ( ROP ) | 50 days |
| Necrotizing Entero Colitis ( NEC ) | 40 days |
| Length of neonatal intensive care ( NICU ) and hospital stay | 90 days |
| Air-leak syndrome | Development of pneumothorax or pneumomediastinum | 14 days |