Clinical Research Directory

Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia

The goal of this clinical trial is to learn if caffeine citrate prevents apneic events that result in sick visits in moderately preterm infants after discharge from the hospital. It will also learn if the use of caffeine leads to better developmental outcomes at 12 months of age. Our research questions are: 1. Does continued treatment of moderately preterm newborns with caffeine citrate after hospital discharge prevent or decrease apneic events that result in sick visits? 2. Will the continued use of caffeine citrate lead to improved developmental outcomes among infants at 12 months of age? Researchers will compare caffeine citrate to a placebo (a look-alike substance that contains no drug) to see if caffeine citrate prevents apneic spells which result in healthcare visits. Parents of participants will: 1. Administer caffeine citrate 20mg/kg/day or a placebo (equivalent volume of sterile water) orally every day for up to 28 days after hospital discharge 2. Keep a diary of symptoms and any apneic events 3. Check in with researchers via telephone call once a week 4. Return to clinic for infant physical examination at 28 days 5. Return to the clinic for infant physical examination at 2 months 5\. Return to clinic for infant neurodevelopmental examination with Ages and Stages Questionnaire at 12 months of age

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

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.

Efficacy of PIMUN by Reducing Intermittent Hypoxia Events

The goal of this clinical trial is to learn if the use of PIMUN(medical device) works to reduce the intermittent hypoxemia of 24-34 weeks of birth gestational age babies. . It will also learn about the safety of the use of PIMUN. The main questions it aims to answer are: Does PIMUN lower the time of oxygen saturation under 90%? What medical problems do participants have using PIMUN? Researchers will compare the use of PIMUN during 48 hours to 48 hours of usual treatments (not using PIMUN). Participants will: Use/ or not use of PIMUN for a 48 hours period- randomly assigned. Regional brain oxygenation by near infrared spectroscopy (NIRS) monitoring at the first day of each 48 hours period. 4-6 hours of polysomnography at the second day of each intervention. Plasma and urine stress oxygen metabolites at the end of each 48-hours intervention.

The Role of Electroencephalography in Caffeine Discontinuation Timing in Premature Infants

The aim of this observational study is to investigate whether functional maturation assessment by electroencephalography in preterm infants can provide reliable data for the safe discontinuation of caffeine therapy without recurrence of apnea. In preterm infants receiving caffeine therapy, an assessment of maturation will be performed by EEG at the time when discontinuation of caffeine treatment is planned.

The Effect of Caffeine Therapy in Cardiovascular Stability in Preterm Neonates at Assiut University Children Hospital NICU

Preterm neonates younger than 37 weeks gestational age receiving caffeine therapy for apnea of prematurity in a NICU setting.

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

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.

Caffeine Use in the Management of Preterm Infants

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

The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study

Diagnostic investigations in paediatric respiratory and sleep medicine are often challenging due to patient size (due to prematurity), tolerability, and compliance with "gold standard equipment". Children with sensory/behavioural issues, at increased risk of sleep disordered breathing (SDB), often find tolerating standard diagnostic equipment difficult. There is a need to develop non-invasive, wireless, devices designed for the paediatric population. Devices must address health in-equalities as high-risk children, with low birth weights, genetic syndromes, or complex neuro-disabilities, are often unable to undergo current investigations, particularly in sleep medicine. Prompt and accurate diagnosis of SDB is important to facilitate early intervention and improve outcomes Infants in the neonatal period can have immature breathing control which manifests as excessive central breathing pauses, apnoea's, whilst asleep requiring oxygen therapy. There is also a risk to newborn term infants of sudden unexpected neonatal collapse, even in "low risk" babies. Diagnosis of breathing issues in babies can be challenging since babies are often too small for standard monitoring equipment. Effective monitoring and appropriate treatment of apnoea's has been shown to improve prognosis in terms of 5-year mortality and neurodevelopmental outcomes. Children with epilepsy are at risk of epileptic apnoea during a seizure (ictal) or post-ictal apnoea following an epileptic seizure. Epileptic and post-ictal apnoea have been implicated as causes of sudden unexpected death in epilepsy (SUDEP). Epilepsy affects approx. 50 million people worldwide. The risk of SUDEP varies in different underlying causes of epilepsy but is estimated to be the cause of 1.2 deaths for every 1,000 children with epilepsy each year. This observational study is part of a phased clinical program of research that aims to validate a small wearable biosensor developed by PneumoWave Ltd in a paediatric clinical setting with the overall primary endpoints of monitoring and assessing respiratory pattern as an aid to sleep diagnostics, and as a device to monitor apnoea in neonatal patients and children with epilepsy at risk of SUDEP.

Caffeine Citrate to Improve Neonatal Outcomes.

The goal of this clinical trial to learn what dose/s of caffeine citrate works to treat preterm born babies who have episodes where they stop breathing. It will also learn about the safety of different doses of caffeine citrate for the variety of preterm-born babies that are prescribed this. The main question it aims to answer is: Which dose is the optimal dose of caffeine citrate for very preterm babies to prevent short-term death and disease? Researchers will compare three different doses of caffeine citrate, which are already used in clinical practice to treat breathing stoppages in preterm babies, to see which dose works best. No placebo will be used. Participants will be given a 'loading' dose of caffeine citrate \<72 hours of life, and a smaller 'maintenance' dose once a day, for as long as the baby needs this. This trial will be undertaken as part of the PLATIPUS trial (NCT06461429).

Apnea of Prematurity Results in Respiratory Distress and Cyanosis. Caffeine Citrate Can Treat It.

High-dose caffeine citrate is more effective than low-dose caffeine citrate in the treatment of apnea of prematurity (AOP). The high-dose group showed fewer apnea episodes, higher extubation success rate, lower extubation failure rate and shorter duration of oxygen therapy

"Prapela® SVS Incubator Pad for Apnea of Prematurity

The study proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad with stochastic vibrotactile stimulation (SVS) that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Currently, the only approved therapy for AOP is Caffeine Citrate. The SVS mattress pad can prove to be an effective, non-invasive adjunct to Caffeine Citrate for preterm infants with potential to shorten the need for respiratory support as well as overall shortened length of stay.

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

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.

Doxapram Therapy in Preterm Infants (DOXA Trial)

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).