Premature babies often need help breathing for a longer period of time. Traditionally, this is done with a breathing aid called NCPAP (nasal continuous positive airway pressure). This treatment is safe and effective, but it is very time-consuming and can sometimes have side effects. In the present research project, the investigators want to find out whether another type of breathing aid called NHF (nasal high flow therapy) is just as effective for stable premature babies. The investigators suspect that NHF is just as effective, but easier to use and more comfortable.
This is a multi center parallel group three arm randomized controlled clinical trial investigating cardiorespiratory stability in stable preterm infants receiving NHF. Currently, NCPAP remains the gold standard for administration of prolonged non-invasive ventilatory support in very preterm infants. NHF is a promising method for tailored, less invasive long-term ventilatory support for preterm infants. If ventilatory support with NHF is similarly effective to conventional NCPAP in stable preterm infants, clinicians are likely to adopt this method for widespread clinical use because of its improved comfort and potential other benefits. Primary aim of this trial is to examine cardiorespiratory stability in preterm infants treated with two commonly used NHF flowrates (Interventional group 1 and 2) in comparison to NCPAP (Comparator). Secondary aim is to examine potential comfort-related beneficial effects of NHF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
150
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, Germany
RECRUITINGDepartment of Pediatrics, Inselspital
Bern, Switzerland
RECRUITINGTreatment failure
Treatment failure is a composite outcome defined as meeting one of the following treatment failure criteria within 24 hours of starting of intervention: 1. \>2 apneas with concomitant bradycardias (\<100/min) per hour for \> 1 hour or 2. FiO2 \> 0.3 consistently for \> 1 hour or 3. Significant chest recessions (Silverman Score ≥ 5) for \> 1 hour or 4. Respiratory rate \> 60/min consistently for \> 1 hour or 5. Any need for intermittent positive pressure ventilation The presence of "Treatment failure" within 24 hours of starting of intervention will be documented (dichotomous outcome; yes/no).
Time frame: 24 hours
Apneas and bradycardias
The total frequency of apneas and bradycardias (\<100/min) within 24 hours of starting of intervention will be documented.
Time frame: 24 hours
Respiratory rate (RR)
The mean RR within 24 hours of starting of intervention will be documented.
Time frame: 24 hours
Heart rate (HR)
The mean HR within 24 hours of starting of intervention will be documented.
Time frame: 24 hours
Oxygen saturation (SpO2) and fraction of inspired oxygen (FiO2)
The mean SpO2/FiO2 ratio within 24 hours of starting of intervention will be documented.
Time frame: 24 hours
Frequency of any treatment failure
Treatment failure is a composite outcome (see "Outcome 1"). The frequency of any treatment failure during the duration of the study will be documented.
Time frame: Individual study duration: estimated to be between a minimum of 7 days to an (estimated) maximum of 10 weeks.
Rescue NCPAP
Rescue NCPAP is defined as NCPAP \>6 cm H2O. The frequency of need for Rescue NCPAP during the duration of the study will be collected.
Time frame: Individual study duration: estimated to be between 7 days to 10 weeks.
Postmenstrual age (PMA) off positive pressure support
The investigators will document the PMA when the infant is off positive pressure support.
Time frame: Estimated to be at a PMA of approximately 29 to 34 weeks.
Postmenstrual age (PMA) off FiO2 > 0.21
The investigators will document the PMA when the infant is off FiO2 \> 0.21
Time frame: Estimated to be at a PMA between approximately 28 to 34 weeks.
Postmenstrual age (PMA) at discharge
The investigators will document the PMA when the infant is being discharged from the hospital.
Time frame: Estimated to be at a PMA of approximately 38-40 weeks.
Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after start of the intervention
The cerebral oxygen saturation (cRSO2) in \[%\] 1 hour before until 3 hours after start of the intervention will be measured by using Near-infrared spectroscopy (NIRS).
Time frame: 4 hours
Time spent <55% cRSO2 1 hour before until 3 hours after start of the intervention
The time spent \<55% cRSO2 in \[min\] 1 hour before until 3 hours after start of the intervention will be measured by using Near-infrared spectroscopy (NIRS).
Time frame: 4 hours
Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after cessation of the intervention
The cerebral oxygen saturation (cRSO2) in \[%\] 1 hour before until 3 hours after cessation of the intervention will be measured by using Near-infrared spectroscopy (NIRS).
Time frame: 4 hours
Time spent <55% cRSO2 1 hour before until 3 hours after cessation of the intervention
The time spent \<55% cRSO2 in \[min\] 1 hour before until 3 hours after cessation of the intervention will be measured by using Near-infrared spectroscopy (NIRS).
Time frame: 4 hours
Change in end-expiratory lung impedance (ΔEELI)
The change Δ in end-expiratory lung impedance (ΔEELI) will be measured using electrical impedance tomography (EIT) at 9 different timepoints during the first 48 hours after starting of intervention. One measurement will last 6 minutes. The measurements will take place: * within 30 minutes before starting of intervention (baseline measurement) * 3 minutes before until 3 minutes after starting of intervention * within 30 minutes after starting of intervention * 2, 6, 12, 24, 36, and 48 hours after starting of intervention
Time frame: 48 hours
Change in global inhomogeneity (ΔGI) index
The change Δ in global inhomogeneity (ΔGI) index will be measured using electrical impedance tomography (EIT) at 9 different timepoints during the first 48 hours after starting of intervention. One measurement will last 6 minutes. The measurements will take place: * within 30 minutes before starting of intervention (baseline measurement) * 3 minutes before until 3 minutes after starting of intervention * within 30 minutes after starting of intervention * 2, 6, 12, 24, 36, and 48 hours after starting of intervention
Time frame: 48 hours
Change in variability of tidal volume (ΔTV)
The change Δ in variability of tidal volume (ΔTV) will be measured using electrical impedance tomography (EIT) at 9 different timepoints during the first 48 hours after starting of intervention. One measurement will last 6 minutes. The measurements will take place: * within 30 minutes before starting of intervention (baseline measurement) * 3 minutes before until 3 minutes after starting of intervention * within 30 minutes after starting of intervention * 2, 6, 12, 24, 36, and 48 hours after starting of intervention
Time frame: 48 hours
Change in ratio of tidal volume anterior/posterior (ΔRatio TV ap)
The change Δ in ratio of tidal volume anterior/posterior (ΔRatio TV ap) will be measured using electrical impedance tomography (EIT) at 9 different timepoints during the first 48 hours after starting of intervention. One measurement will last 6 minutes. The measurements will take place: * within 30 minutes before starting of intervention (baseline measurement) * 3 minutes before until 3 minutes after starting of intervention * within 30 minutes after starting of intervention * 2, 6, 12, 24, 36, and 48 hours after starting of intervention
Time frame: 48 hours
Incidence of Bronchopulmonary dysplasia (BPD)
The incidence with specification of severity of BPD at 36 weeks PMA will be documented. BPD is a form of chronic lung disease (CLD). BPD is classified into 3 levels of severity according to the internationally used definition of Jobe and Bancalari (1). FiO2 \>0.21 for ≥ 28 days and 1. Breathing room air (mild) 2. FiO2 \<0.3 (moderate) 3. FiO2 ≥ 0.3 and/or positive pressure support (severe) (1) Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001;163(7):1723-9.
Time frame: At 36 weeks PMA
Urinary cortisol
A 24-hour-urine-sample will be collected on the third study day. The urinary production rates of cortisol and the most important metabolites will be documented as an indicator for infant stress.
Time frame: 24 hours
COMFORTneo score
The COMFORTneo score will be documented on the third, fourth and fifth study day. The score measures comfort and chronic pain by observation.
Time frame: 72 hours
Revised Bernese Pain Scale for Neonates (BSN-R) score
The BSN-R score will be documented on the third, fourth and fifth study day. The score measures pain.
Time frame: 72 hours
Parental assessment of comfort
The parents will be asked 3 predefined questions concerning their infants' comfort on the on the third, fourth and fifth study day.
Time frame: 72 hours
NASA Task Load Index (NASA-TLX)
The NASA-TLX will be filled out by the participants' nurses on the third, fourth and fifth study day. The NASA-TLX is a questionnaire that measures workload.
Time frame: 72 hours
Nasal trauma score
The nasal trauma score is assessed according to internal standard guidelines in case of a present nasal trauma. The highest respective score and time of assessment will be documented on the participant CRF at 36 weeks PMA. Measuring nasal trauma using the Nasal trauma score takes approximately 20 seconds.
Time frame: Individual study duration: estimated to be between 7 days to 10 weeks.
Behavioral Sleep stage classification for Preterm Infants (BeSSPI)
Sleep-wake cycles as determined by the BeSSPI on the fourth study day will be documented. The BeSSPI identifies sleep stages by observation and takes approximately 2.5 hours.
Time frame: 24 hours
Parental Bonding Questionnaire (PBQ)
The score of the PBQ will be documented at 36 weeks PMA. The PBQ investigates infant-parental bonding.
Time frame: At 36 weeks PMA
Age at initiating breastfeeds
The postmenstrual age (PMA) at initiating breastfeeds will be documented. This refers to the PMA at which the first successful breastfeeding attempt takes place.
Time frame: Estimated to be between 30-34 weeks PMA.
Age at reaching full breastfeeds
The postmenstrual age (PMA) at reaching full breastfeeds will be documented. This corresponds to 100% nutrition per breastfeeds for 24 consecutive hours.
Time frame: Estimated to be between 34-40 weeks PMA.
Weight
The weight in \[g\] at 36 weeks postmenstrual age (PMA) will be documented.
Time frame: At 36 weeks PMA
Head circumference
The head circumference in \[cm\] at 36 weeks postmenstrual age (PMA) will be documented.
Time frame: At 36 weeks PMA
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