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Apnea of Prematurity clinical trials

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NCT ID: NCT06401083 Recruiting - Respiratory Failure Clinical Trials

The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate

NEOKOFF22
Start date: December 21, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to answer whether the use of a single loading dose (20 mg/kg) of caffeine citrate one hour before extubation has an impact on the success rate of extubation among preterm neonates. In addition, the investigators would like to assess the frequency of apneas and side effects of the intervention, as well as the development of NEC, BPD, IVH, PVL, and long-term neurodevelopmental outcomes in the investigated populations. According to institutional protocol, preterm infants born before the 32nd week of gestation receive a standard dose of caffeine citrate therapy. This covers a maintenance dose of 5-10 mg/kg of caffeine citrate administered intravenously once or twice daily after a loading dose of 20 mg/kg on the first day of life. In this trial, preterm infants born before the 32nd gestational week and who had been mechanically ventilated for at least 48 hours before planned extubation are planned to be randomly allocated into intervention and control groups. The intervention group will receive an additional loading dose of caffeine citrate 60 minutes before extubation. The control group will receive standard dosing regimens.

NCT ID: NCT06327152 Recruiting - Clinical trials for Apnea of Prematurity

Caffeine Use in the Management of Preterm Infants

Start date: February 22, 2024
Phase: Phase 2
Study type: Interventional

This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.

NCT ID: NCT05968586 Recruiting - Premature Clinical Trials

Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants

Start date: September 11, 2023
Phase: N/A
Study type: Interventional

This research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to expand and fill with air), and how frequently the baby develops clinically significant events such as apnea (baby stops breathing on his own), bradycardia (low heart rate), and desaturation (low oxygen) events.

NCT ID: NCT05878925 Recruiting - Prematurity Clinical Trials

Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants

NOSE
Start date: June 14, 2023
Phase: N/A
Study type: Interventional

This trial analyzes the effect of an olfactory stimulation with vanilla or strawberry aroma compared to placebo on desaturations and bradycardia in preterm infants with apnea of prematurity. Infants on continuous positive airway pressure (CPAP) support will be included and the aroma will be applied to the inner surface of the CPAP mask using designated scent pens. The trial uses a cross-over design. Infants are randomised to begin the study with either aroma or placebo which will be applied into the breathing mask every 3 to 4 hours during 12 hours for each of the two intervention periods. Identically looking pens with either aroma or placebo are used and patients, parents, medical staff and the study team are blinded to this allocation. Infants are monitored with an oximetry sensor to measure peripheral oxygen saturation (SpO2) and pulse rate.

NCT ID: NCT05298748 Recruiting - Bradycardia Clinical Trials

The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants

Start date: September 16, 2022
Phase: N/A
Study type: Interventional

The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants.

NCT ID: NCT05196646 Recruiting - Clinical trials for Apnea of Prematurity

Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on CPAP

DREAM
Start date: December 5, 2022
Phase:
Study type: Observational

This is an observational, proof-of-concept, feasibility study where 50 preterm infants with gestational age < 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal Children's Hospital. The study's primary objective is to describe the relationship between respiratory acoustics and airflow and determine the reliability of a novel respiratory acoustic sensor at detecting breathing sounds in preterm infants. The study's secondary objectives are: 1. To compare transthoracic impedance, respiratory inductive plethysmography and an inertial measurement unit for the detection of respiratory efforts in preterm infants. 2. To evaluate the feasibility and accuracy of a novel, non-invasive method for continuously detecting and differentiating cardiorespiratory events in preterm infants on CPAP by integrating measurements of respiratory effort with respiratory acoustic monitoring.

NCT ID: NCT04430790 Recruiting - Clinical trials for Respiratory Insufficiency

Doxapram Therapy in Preterm Infants (DOXA Trial)

Start date: June 15, 2020
Phase: Phase 3
Study type: Interventional

Preterm infants often suffer from apnea of prematurity (AOP; a cessation of breathing) due to immaturity of the respiratory system. AOP can lead to oxygen shortage and a low heart rate which might harm the development of the newborn, especially the central nervous system. In order to prevent oxygen shortage, infants are treated with non-invasive respiratory support and caffeine. Despite these treatments, many preterm newborns still suffer from AOP and need invasive mechanical ventilation. Although this will result in complete resolution of AOP, invasive mechanical ventilation has the disadvantage of being a major risk of chronic lung disease and impaired neurodevelopmental outcome. Restrictive invasive ventilation is therefore advocated nowadays in preterm infants. Doxapram is a respiratory stimulant that has been administered off-label to treat AOP. Doxapram, as add-on treatment, seems to be effective in treating AOP and to prevent invasive mechanical ventilation. It is unclear if a preterm infant benefit from doxapram treatment on the longer term. This study compares doxapram to placebo and hypothesizes that doxapram will protect preterm infants from both invasive ventilation (and related lung disease) and AOP related oxygen shortage (and related impaired brain development).

NCT ID: NCT04144712 Recruiting - Clinical trials for Apnea of Prematurity

Caffeine as Respiratory Stimulant in Preterm Infants

Start date: April 1, 2019
Phase: Phase 1
Study type: Interventional

comparison between rate of occurance of apnea of prematurity AOP when using high and low dose caffeine

NCT ID: NCT03670732 Recruiting - Clinical trials for Respiratory Distress Syndrome

CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure

NICA
Start date: September 30, 2017
Phase: N/A
Study type: Interventional

This study seeks to determine if standard continuous positive airway pressure, known as CPAP is as effective as a more complicated approach that generates intermittent increases in airway pressure applied to the nostrils via a breathing machine. The latter is known as NIPPV and requires costly equipment to operate. Previous studies did not ensure that the average pressure applied to the lungs was equal and thus did not make for a fair comparison. The investigators believe that when the same average pressure is applied with the two techniques, CPAP is just as effective as NIPPV and may have fewer side effects, such as blowing air into the stomach. Each baby will receive CPAP or NIPPV in a random sequence for a period of 12 hours, followed by 12 hours on the alternate technique.

NCT ID: NCT03651648 Recruiting - Clinical trials for Apnea of Prematurity

Apnea Treatment in Premature Infants Using an Automatic Vibro-tactile Stimulator Triggered by the Detection of Apnea-bradycardia.

SENSITACT
Start date: October 18, 2019
Phase: N/A
Study type: Interventional

The goal of the SENSITACT system is to activate an adaptive kinesthetic stimulation to treat apnea-bradycardia events on preterm infants, while minimizing deleterious effects, in particular arousals that can be due either to respiratory efforts or to kinesthetic stimulation itself. This novel system will provide an alternative treatment to apnea-bradycardia, with improved patient comfort and autonomy. In particular, it may become a complementary solution for the current treatments (Manual stimulation by caregivers, continuous or intermittent nasal positive pressure ventilation and methylxanthine therapies) that do not appear to be optimal and usually only allow a partial reduction in the number and severity of apneas.