Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Ankara University | Other Grant/Funding Number | Ankara University Research Fund (Number 10B3330010) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether the immediate bolus strategy combined with early nasal CPAP (nCPAP) treatment could decrease the subsequent need for ventilation compared to the administration of surfactant prophylaxis at 15 minutes after birth with early nCPAP in premature infants.
Respiratory distress syndrome (RDS) is a syndrome in premature infants caused by developmental insufficiency of surfactant production and structural immaturity in the lungs. Exogenous surfactant therapy has become well established in newborn infants with RDS. Surfactant replacement therapy, either as a rescue treatment or a prophylactic, reduces mortality and several aspects of morbidity in babies with RDS. It is known that infants who are at a significant risk of RDS should receive prophylactic surfactant therapy, but the optimal timing and strategy for prophylactic surfactant therapy remains controversial. When administered immediately after delivery, surfactant mixes with the fetal lung fluid and reaches the alveoli before the onset of lung injury potentially created by the first applied positive pressure ventilation. As another approach, surfactant prophylaxis may be administered after resuscitation and stabilization.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immediate bolus surfactant | Experimental |
| |
| post-resuscitation surfactant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surfactant prophylaxis | Other | Premature infants born before 28 weeks' gestation and infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery to receive either immediate bolus or post-resuscitation surfactant prophylaxis at 15 minutes after birth. Those infants who were randomized to immediate bolus surfactant were intubated as rapidly as possible after birth, were administered 100 mg/kg surfactant (Curosurf[Chiesi, Farmaceutici, Parma, Italy]), and received standard resuscitation measures as indicated. Those infants who were randomized to post-resuscitation surfactant received standard resuscitation measures first, were intubated electively at 15 minutes after birth and received 100 mg/kg surfactant (Curosurf[Chiesi, Farmaceutici, Parma, Italy]). |
| Measure | Description | Time Frame |
|---|---|---|
| ventilatory requirement | Infants with RDS may require mechanical ventilation. Mechinal ventilation causes volu- and barotrauma in the lungs and associated morbidities. The earlier surfactant is given, the better it works. So immediate surfactant prophylaxis given before the first breath may decrease the requirement for mechanical ventilation compared with surfactant prophylaxis given at 15 minutes of age after resuscitation and stabilization. | within the first 5 days of life |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumothorax | first 72 hours of life | |
| Pulmonary hemorrhage | first 72 hours of life | |
| patent ductus arteriosus |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saadet Arsan, Professor | Contact | 90 312 5956390 | Saadet.Arsan@medicine.ankara.edu.tr | |
| Emel Okulu, MD | Contact | 90 312 5956390 | emelderelli@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Saadet Arsan, Professor | Ankara University Faculty of Medicine | Study Director |
| Emel Okulu, MD | Ankara University Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara University Faculty of Medicine Department of Pediatrics | Recruiting | Ankara | 06620 | Turkey (Türkiye) |
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| first one week |
| necrotizing enterocolitis | first one month |
| retinopathy of prematurity | first two months |
| intraventricular hemorrhage | first one week |
| bronchopulmonary dysplasia | first two months |
| duration of hospitalization | one year |
| mortality | one year |
| D000091642 | Urogenital Diseases |