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Evaluating the effect of early application of Continuous positive airway pressure (CPAP) via Neopuff in cases of transient tachypnea of the newborn(TTN) and its role in decreasing the duration and complication of TTN.
The aim of the study is to determine whether positive end expiratory pressure therapy (PEEP) administered early via a T piece based infant resuscitator (Neopuff) would safely reduce the incidence of TTN and the need for neonatal intensive care unit (NICU) admission of near term and term infants with respiratory distress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neopuff group | Experimental | includes 34 newborns showing signs of TTN who received CPAP (5 cm of H2O) via T- piece (Neopuff; Fisher and Paykel Healthcare, Auckland, New Zealand). |
|
| Control group | No Intervention | includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neopuff | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Need for admissions to NICU secondary to TTN | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of plasma brain natriuretic peptide and clinical outcome [Time Frame: 24 hours]. | 24 hours | |
| Duration of tachypnea. | until discharge | |
| Duration and type of oxygen therapy. |
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Inclusion Criteria:
Exclusion Criteria:
Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥48 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization.
Presence of any other cause of respiratory distress, eg.
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| Name | Affiliation | Role |
|---|---|---|
| Rania A. El-Farrash, MD, PhD | Associate Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt | Principal Investigator |
| Amani O. Mahmoud, MD | Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt | Study Chair |
| Enas H. Abdul-Hady, M.B.B.Ch | Ministry of Health | Principal Investigator |
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| ID | Term |
|---|---|
| D059245 | Transient Tachypnea of the Newborn |
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
|
| ntil discharge |
| Antibiotic treatment. | until discharge |
| Incidence of pulmonary air leaks | ntil discharge |
| Length of hospital (NICU) stay | until discharge |
| Death | until discharge |
| D012120 | Respiration Disorders |
| D059246 | Tachypnea |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |