Table 2 Maternal, perinatal, and neonatal data to be collected for each participant
Area | Data to be collected |
|---|---|
Maternal | Age, parity, HIV status, antenatal attendance, last normal menstrual period, expected delivery date, time/date of rupture of membranes, time/date of onset of labor, dexamethasone administration, antibiotic administration |
Birth | Time/date of birth, type of delivery, condition at birth, type of resuscitation required, medications administered at birth, time CPAP initiated if in the intervention arm |
Neonatal | Time of admission to the neonatal unit, vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation, and temperature), weight, length, and occipital-frontal circumference on admission to the neonatal unit, medications given at admission and during the stay, respiratory support given at admission and during the stay |
Respiratory Distress Syndrome | The level of respiratory distress will be evaluated using the Downe’s Score (Supplement 1) [36]. The Downe’s score will be recorded every 4 h until CPAP is discontinued. Downe’s score includes 5 criteria: respiratory rate, retractions, cyanosis, air entry, and grunting. Each of these is rated on a scale of 0, 1, 2. The total score is then evaluated as no respiratory distress (< 4), respiratory distress (4–7), and impending respiratory failure (> 7) |
Cardiology | Evidence of haemodynamically significant patent ductus arteriosus (hsPDA) in echocardiogram performed at 72 h. The M-Turbo Sonosite™ will be used together with a p10x cardiac probe (4-8MHx). All doctors in the study will be trained by the study cardiologist to perform bedside echocardiograms. All practitioners who perform echocardiograms will follow the same protocol of standard transthoracic views including the subcostal, parasternal long and short axis views, and the ductal view. The ductal view will confirm the diagnosis of PDA. A local reading of the echocardiogram will be done by the clinical team and the neonate will be treated as per local protocols. Videos of each echocardiogram will be recorded and shared with the cardiologist for evaluation of the presence of hsPDA. A hsPDA will be defined if left-to-right shunting through the PDA is accompanied by two left atrial to the aortic root (LA:Ao) ratio of ≥ 1.5, and/or retrograde diastolic flow in the descending aorta, and/or a moderate to large PDA ≥ 1.5 mm, and/or increased LV end-diastolic diameter z-score for age, weight, and length. The cardiologist will be blinded to any demographic or clinical details of the neonate and the trial allocation group |
Blood pressure | The diastolic and systolic blood pressure will be measured and recorded daily |
Brain imaging | Cranial ultrasound examinations will be performed on day 1, day 3, day 7, and day 28 or at discharge if earlier. The ultrasound images will be evaluated for evidence and grade of any intraventricular hemorrhage. The M-Turbo Sonosite ™ will be used together with a curvi-linear (Cx11) probe. All doctors in the study will be trained to perform a cranial ultrasound by a senior neonatologist with extensive experience in performing and interpreting cranial ultrasounds. All practitioners who perform cranial ultrasounds will be taught to follow the same protocol and record a standard set of coronal and sagittal images via the anterior fontanelle Images with be saved and shared with the senior neonatologist for evaluation of the presence of IVH and cerebellar hemorrhage. The transverse cerebellar diameter (TCD) will be measured as an indicator of gestational age [49]. The neonatologist will be blinded to any demographic or clinical details of the neonate and the trial allocation group. The severity of the IVH will be graded using the following Papile criteria [50]: • Grade 1: Bleeding confined to the germinal matrix • Grade 2: Bleeding into the lateral ventricle but not causing ventricular distension • Grade 3: Bleeding into the lateral ventricle causing acute ventricular dilation • Grade 4: Haemorrhagic parenchymal infarction |
Lung ultrasound | Lung ultrasound (LUS) will be performed on admission and daily thereafter until CPAP is discontinued. LUS will be evaluated for evidence of respiratory distress syndrome, consolidation, pleural effusion, and pneumothorax [51]. The M-Turbo Sonosite ™ will be used together with a high-resolution linear probe (SLAx). All doctors in the study will be trained to perform a lung ultrasound by an anaesthesiologist with experience in performing and interpreting lung ultrasounds. All practitioners who perform lung ultrasounds will be taught to follow the same protocol. Videos will be saved and shared with the anaesthesiologist for evaluation of the presence of lung pathology. The anesthesiologist will be blinded to any demographic or clinical details of the neonate and the trial allocation group. The LUS will be assessed for the presence or absence of pneumothorax and given a LUS score. The LUS will be scored by dividing each lung into 3 areas and scoring each area from 0 to 3 depending on the 4 different patterns that can be seen [51] |
Nasal septal erosions | Evaluated at randomization to allow baseline documentation of the nasal septum in all infants. In the intervention infants, the septum will be evaluated when the portable CPAP is discontinued, either to stop CPAP completely or to change to BCPAP. The septum will then be evaluated daily until CPAP is weaned. Severity will be documented in the CRF with an accompanying photo. The septal erosions will be graded using the following criteria: 1. Nil 2. Erythema or pressure indentation 3. Superficial erosion 4. Septal necrosis |
In hospital survival | Time and date of death or date of discharge will be recorded. Infants will be followed up until 28 days |