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| ID | Type | Description | Link |
|---|---|---|---|
| U10HD021364 | U.S. NIH Grant/Contract | View source | |
| M01RR000080 | U.S. NIH Grant/Contract | View source | |
| U10HD034216 | U.S. NIH Grant/Contract | View source | |
| U10HD027853 | U.S. NIH Grant/Contract | View source | |
| M01RR008084 | U.S. NIH Grant/Contract | View source | |
| U10HD021397 | U.S. NIH Grant/Contract | View source | |
| M01RR016587 | U.S. NIH Grant/Contract | View source | |
| U10HD040461 | U.S. NIH Grant/Contract | View source | |
| U10HD036790 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).
Previous studies suggested that early continuous airway positive pressure (CPAP) may be beneficial in reducing ventilator dependence and subsequent bronchopulmonary dysplasia (BPD) in extremely low birth weight (ELBW) infants. These studies did not test for the optimal timing of CPAP initiation or compare CPAP/PEEP initiation in the delivery room against standard resuscitation methods. Current practice at the time was for the ELBW infant to be intubated early and administered prophylactic surfactant. The feasibility of initiating CPAP in the DR and continuing this therapy without intubation for surfactant had not been determined prospectively in a population of ELBW infants.
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP/PEEP Intervention | Experimental | Infants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV. |
|
| Control | Active Comparator | Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP/PEEP | Device | Infants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV. |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance with the study protocol | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of resuscitation needed | Until admission to NICU | |
| Five minute Apgar | 5 minutes after birth | |
| Total duration of mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil N. Finer, MD | University of California, San Diego | Study Director |
| Avroy A. Fanaroff, MD | Case Western Reserve University, Rainbow Babies & Children's Hospital | Principal Investigator |
| Waldemar A. Carlo, MD | University of Alabama at Birmingham | Principal Investigator |
| Edward F. Donovan, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Charles R. Bauer, MD | University of Miami | Principal Investigator |
| W. Kenneth Poole, PhD | RTI International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of California at San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15342835 | Result | Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK; National Institute of Child Health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics. 2004 Sep;114(3):651-7. doi: 10.1542/peds.2004-0394. |
| Label | URL |
|---|---|
| NICHD Neonatal Research Network | View source |
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|
| Standard management practices | Device | Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used. |
|
| Until hospital discharge or 120 days of life |
| Proportion of infants requiring surfactant | 1 day of life |
| Bronchopulmonary dysplasia (BPD) | 36 weeks of life |
| Number and duration of intubation attempts | Until admission to the NICU |
| Infants who required positive pressure ventilation for resuscitation in the DR/resuscitation room | Until admission to the NICU |
| San Diego |
| California |
| 92103-8774 |
| United States |
| University of Miami | Miami | Florida | 33136 | United States |
| RTI International | Durham | North Carolina | 27705 | United States |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45267 | United States |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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