Premature Newborns Treated With Less Invasive Surfactant Administration Under Heated Humidified High-flow

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-10

Study Completion Date

2017-12-30

Brief Summary

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Nasal Continuous Airway Pressure (CPAP) or Heated humidified high-flow Air support with nasal cannula (HHHFNC) are among the most commonly used non-invasive respiratory support methods. The purpose of this prospective study was to compare vital findings, blood gas parameters, perfusion index (PI) and plethysmographic variability index (PVI) values in premature infants treated with less invasive surfactant administration (LISA) under HHHFNC or CPAP.

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Detailed Description

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Nasal Continuous Airway Pressure (CPAP) or Heated humidified high-flow Air support with nasal cannula (HHHFNC) are among the most commonly used non-invasive respiratory support methods. The purpose of this prospective study was to compare vital findings, blood gas parameters, perfusion index (PI) and plethysmographic variability index (PVI) values in premature infants treated with less invasive surfactant administration (LISA) under HHHFNC or CPAP. This study was carried out in Hacettepe University Hospital NICU between January and December 2017. Premature newborns who were on noninvazive respiratory support and were diagnosed as RDS within first 72 hours of life, were taken into the study. Noninvasive respiratory support was provided with nasal CPAP or HHHNFC. Pulse oxymetry measurements were obtained before and 5th, 30th, 60th, 120th , 360th minutes, blood gas analysis was performed immediately before and 120th, 360th minutes after surfactant administration.

Post-hoc, one-way difference between two independent means (two groups) statistical analysis was used. Significance P \< 0.05; effect size 0.9; power (1-ß err prob) was found to be 82%.

Conditions

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Respiratory Disease Newborn Rds

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Premature newborns (gestational age \<370/7 weeks) who did not require intubation, who were diagnosed with RDS, and who were treated with surfactant in the first 72 hours of life were included in the study. Written informed consent was obtained from all of the infants' families before the infants were enrolled in the study. Noninvasive respiratory support was provided by nasal CPAP or HHHNFC, respectively, according to the time of admission to the intensive-care unit, so the patients were divided into two groups. During the study period, the noninvasive respiratory support method (nasal CPAP or HHHNFC) that the babies received did not change.

Post-hoc, one-way difference between two independent means (two groups) statistical analysis was used. Significance P \< 0.05; effect size 0.9; power (1-ß err prob) was found to be 82%.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP group

A Babylog 8000 neonatal ventilator (Dräger, Lübeck, Germany) for nasal CPAP support was used support . The nasal CPAP support had been applied through short binasal prongs (Optiflow Junior 2 nasal cannula) used as an interface. PEEP pressure was set to 6-8 cmH2O for nasal CPAP. The FiO2 was regulated to keep the oxygen-saturation value between 92% and 95%.

Group Type ACTIVE_COMPARATOR

Nazal CPAP

Intervention Type DEVICE

HHHFNC group

A Vapotherm® device (Vapotherm Inc., Stevensville, MD) for HHHFNC support was used. The airflow rate was set to 6-8 L/min for HHHFNC (heat: 37 °C). The HHHFNC support had been applied through the small bore cannula in the Vapotherm as an interface. The FiO2 was regulated to keep the oxygen-saturation value between 92% and 95%.

Group Type ACTIVE_COMPARATOR

Heated humidified high-flow air support with nasal cannula

Intervention Type DEVICE

Interventions

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Nazal CPAP

Intervention Type DEVICE

Heated humidified high-flow air support with nasal cannula

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Does not require intubation,
* Diagnosed with RDS
* Premature newborns receiving surfactant therapy in the first 72 hours of life
* Those whose families give written consent

Exclusion Criteria

* Babies whose families do not give written consent
* Newborns diagnosed with early neonatal sepsis
* Newborns with inotropic requirements
* Neonates with hemodynamically significant PDA
* Babies of diabetic mothers
* Babies with a major congenital anomaly
* Newborns with hemodynamic instability,
* Those requiring endotracheal intubation,
* NEC (Stage 2 or higher),
* Those showing ICH (Stage 2 or higher)
* Babies with perfusion disorders in the first three days

Minimum Eligible Age

1 Minute

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No