Participants
This randomized control trail study was conducted among 60 infants suffering from RDS in Imam Khomeini Hospital Complex, Valiasr Hospital, in Tehran city, during 2018. Infantsin the neonatal intensive care unit (NICU) of Valiasr Hospital participated in the study. Overall, 60 infants were randomly divided in two CPAP and HFNC treatment group.
Inclusion and Exclusion Criteria
Only the infant’s with mild to moderate RDS, birth weight less than 2000 grams, gestational age less than 34 weeks, respiratory severity between 4 to 7 score, and requires oxygen 60% or less were eligible to participate in this study. As well as, infants who had heart, digestive and respiratory anomalies, intraventricular hemorrhage (IVH) at birth, persistent air leak, sepsis positive at hospitalization in NICU, and Apgar score of less than 5 at 5 minutes were considered to exclusion criteria in this study.
Procedure
Newborns were enrolled at birth and diagnosis of RDS. Before the arrival of the infants, informed consent was obtained from the parents of the infant’s newborn. Before the implementation of the program, the neonates in the two groups were evaluated for the underlying variables and clinical conditions such as: mothers age, weight, length, baby's head circumference, gestational age, apgar at 1 minute after birth, apgar at 5 minutes after birth, and need of oxygen) were considered in this regard mach. Chest X-ray was used to reject other differential diagnosis of respiratory distress. Brain sonography was also used to diagnose ventricular hemorrhage. Both treatments method were performed by one pediatrician for infants.
CPAP treatment was 4 to 6 cm water and FIO2 equivalent to 30% to improve respiratory distress and to reduce the need for oxygen for newborns. The positive pressure created by the device for the infants was measured by a manometer at the beginning of the respiratory tube expiratory arm. It should be noted that treatment was carried out on infants in supine position.
Infants in another group were treated with HFNC methods, and this method continued to improve respiratory distress and eliminate the need for oxygen. Oxygen was heated with a blender unit with a temperature of 32 to 35 °C, and the infant’s mouthwaskeptopen during the use of the upper flow. Regulation flow was calculated based on the following formula: flow rate (liters per minute) = weight (kilograms) & 0.86 + 0.92
In both treatment groups, the administration of surfactant was 80mg /kg and prior to administration of surfactant, the Arterial Blood Gas (ABG) test was performed. As well as, when the infants have no signs of respiratory and tachycardia, and the need for auxiliary oxygen to 25% or less, it was considered as the time to stop respiratory support.
Treatment failure
Therapeutic failure was defined as increasing oxygen demand up to 96 hours after birth and requiring intubation with PH <7.25, Pco2> 60, Pao2 <50 and Fio2> 60%.
Measures
Data was collected by trained nurse and included, infant sex (male, female), gestational age (week), mothers age (years), infants weight (gram), infant length (centimeter), baby's head circumference (centimeter), Apgar at 1 minute after birth (score), Apgar at 5 minute after birth (score), Pneumothorax (yes, no), Patent Ductus Arteriosus-PDA (yes, no), chronic lung disease (yes, no), surfactant injection (yes, no), tracheal intubation (yes, no), death (yes, no), necrotizing enterocolitis -NEC (yes, no), number until full feeding days (days), duration of hospitalization (days), number of oxygen therapy days (days) and testament methods (CPAP, HFNC).
Ethical Approval
Ethical approval was obtained from the research ethics board of the Tehran University of medical sciences (IR.TUMS.IKHC.RCRT.1395.1477).
Data Analyses
Data analyses were conducted by using SPSS-16. Independent t-test and logistic regression were employed to determine comparability of the CPAP testament group in compare with HFNC group.