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This is a randomized controlled study to investigate the effect of application of sustained lung inflation (SLI) at birth on the respiratory outcome of preterm infants with respiratory distress syndrome.
Enrolled infants (n=160) were randomized before birth into 2 groups (intervention and control group) in a ratio 1:1. Randomization was done through an online randomizer (www.graphpad.com), and sealed envelopes were used to assign the infant to one of the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sustained lung inflation | Experimental | Participants in this arm (n=80) received:
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| Control | Other | Participants in this arm (n=80) received:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sustained lung inflation (SLI) | Procedure | SLI was given using a peak pressure of 20 cm H₂O sustained for 15 seconds,using a T-piece resuscitator, Neopuff device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Need for invasive mechanical ventilation or death | Treatment failure; defined as the need for intubation and invasive mechanical ventilation or death | From birth up to 72 hours of life |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of invasive mechanical ventilation | The duration of intubation and invasive mechanical ventilation (in days) | From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days |
| Pneumothorax |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasralainy Cairo University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33254237 | Derived | Abuel Hamd WA, El Sherbiny DE, El Houchi SZ, Iskandar IF, Akmal DM. Sustained Lung Inflation in Pre-term Infants at Birth: A Randomized Controlled Trial. J Trop Pediatr. 2021 Jan 29;67(1):fmaa097. doi: 10.1093/tropej/fmaa097. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Continuous positive airway pressure (CPAP) | Procedure | CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device. |
|
Pneumothorax, documented by radiological findings |
| From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days |
| Bronchopulmonary dysplasia | Bronchopulmonary dysplasia, defined as the need for more than 21% oxygen for at least 28 days | Assessed at 36 weeks postmenstrual age or discharge, whichever came first |
| D000091642 | Urogenital Diseases |
| D012138 |
| Respiratory Therapy |