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Preterm Infant clinical trials

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NCT ID: NCT05399914 Recruiting - Preterm Infant Clinical Trials

Feasibility and Reliability of Synchronized Non-invasive Intermittent Positive Pressure Ventilation in Preterm Infants After Birth

SenSyNoPP
Start date: April 22, 2022
Phase:
Study type: Observational

The aim of this prospective observational study (pilot study) is to test if synchronized noninvasive positive pressure ventilation (S-NIPPV) is feasible and works appropriately during transition from intrauterine to extrauterine life in very preterm infants in the delivery room.

NCT ID: NCT04241263 Recruiting - Preterm Infant Clinical Trials

Neonatal Wireless Monitoring System for Intensive Care

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

Babies who require intensive care need to have their heart rate, oxygen levels and temperature measured continuously using specially designed monitors. These monitors allow the clinical team to constantly assess the baby and see if they are becoming unwell. However, these monitors each have separate wires to connect them to the baby. Another important part of care in these babies is being able to allow parents to hold their babies, getting them out of their incubators to be cuddled. This is called Kangaroo care and has been shown to impact on long term health for both babies and parents. We have designed a system to free babies of the wires that tether them to the monitors. This system has been tested in adults and we now want to test them on the babies. There are two study parts with two different questions: 1. How good is the data? This will compare the new wireless system with the existing system. Babies will have both standard wired monitors and the new wireless monitor on at the same time so we can compare the data to see how good is the quality of the data collected on the new system. 2. What do parents and staff think about the wireless system during Kangaroo care? Babies who no longer need monitoring (but who previously had been monitored with the wired system), will have the wireless system attached and the parent will take their baby from the cot for Kangaroo Care. After the baby has been placed back in the cot, we will conduct interviews with the parent and the nurse to find out what they thought of the new system. We hope this will help the investigators to understand about how good the data is we collect and how we might be able to improve the system.

NCT ID: NCT03919188 Recruiting - Preterm Infant Clinical Trials

Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity

ThermoKPreterm
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Previous studies have shown that mortality and morbidity in preterm neonates are correlated with the fall in body temperature on admission. Hypothermia can be decreased by reducing body heat losses to the environment. The investigator research hypothesis is that a new calculation of the air temperature in the incubator would promote the newborn infant weight growth from the period between birth and day 10 of life compared to cutaneous mode. The secondary hypotheses assumes a decrease in the side effects usually observed in both morbidity and mortality. A software is used to calculate the body heat loss (BHL) of each individual preterm infant, and to propose a specific air temperature setting inside the incubator to reduce BHL to zero. This software has been validated in a previous pilot study (Degorre et al. 2015). This study aims to compare the energy costs of providing incubated preterm infants born between 25 and 32 weeks of gestation with homeothermia using either specific individualized air temperature control (ATC) or skin servocontrol (SSC).

NCT ID: NCT03853161 Recruiting - Preterm Infant Clinical Trials

High Flow Nasal Cannula Versus Nasal Intermittent Positive Pressure (NIPPV) in Preterm Infants

VAPORAM
Start date: January 21, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to compare the effectiveness of Heated Humidified High Flow Nasal Cannula (HHHFNC) versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) in preventing intubation when used as primary respiratory support for Respiratory Distress Syndrome (RDS) or post extubation in preterm infants

NCT ID: NCT03852134 Recruiting - Preterm Infant Clinical Trials

Milking of the Cut-Cord During Resuscitation of Preterm Infants (The MOCC Study)

MOCC
Start date: February 7, 2019
Phase: N/A
Study type: Interventional

In this feasibility study, the investigators will randomize preterm infants born at <32 weeks gestation to either the standard practice of delayed cord clamping (DCC) for 30-60 seconds at birth or milking of the long-cut cord (MOCC) while providing resuscitation/stabilization to the infant. The main objectives of the trial are to assess the feasibility of the new approach (MOCC) and to compare the two groups regarding the hemoglobin levels on admission to NICU in addition to neonatal morbidity and mortality.

NCT ID: NCT03842462 Recruiting - Preterm Infant Clinical Trials

NHFOV vs NIPPV vs nCPAP in Preterm Infants With Respiratory Distress Syndrome

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

This will be a prospective, multi-center, three-arms,parallel, randomized, controlled trial with a superiority design,conducted in China. The investigators conduct this multi-centre, randomized, controlled trial to test the hypothesis that NHFOV is more effective than nCPAP or NIPPV in the treatment of respiratory distress syndrome (RDS) in infants with a gestational age of less than 30 weeks or a birth weight of less than 1500g when used as a primary noninvasive ventilation (NIV) mode.

NCT ID: NCT03660358 Recruiting - Preterm Infant Clinical Trials

Effect of Kinesiotaping Application in Preterm Infants Undergoing Noninvasive Ventilation

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

Kinesiotaping (KT) applied to the thorax is believed to enhance breathing by supporting the respiratory muscles. Infants born premature usually have respiratory problems because of depletion of surfactant and respiratory muscle weakness. Therefore, we are going to use KT for premature infants in NICU who are undergoing non-invasive ventilation. Forty-two participants divided into two groups. The first group will be applied KT to chest wall, abdomen and diaphragm, and the other group will not receive any KT application during non-invasive ventilation. KT application will be going on as long as the infant underwent non-invasive ventilation. We are going to measure blood gas parameters (pH, pCO2, pO2, base excess), respiration rate, peak heart rate, percentage of Fio2, FiO2/pO2 rate, PEEP and PIP values before non-invasive ventilation, 2 hours after non-invasive ventilation, within 72 hours and shortly before weaning from non-invasive ventilation.

NCT ID: NCT03592134 Recruiting - Clinical trials for Respiratory Distress Syndrome

Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns

Start date: February 22, 2018
Phase:
Study type: Observational

Noninvasive respiratory supports (NRS), such as continuous positive airway pressure (CPAP), noninvasive ventilation, high flow nasal cannula (HFNC) or nasal oxygen (O2), are commonly used in preterm newborns hospitalized in neonatal intensive care unit. However, given the lack of validated criteria, clinicians usually choose the NRS according to clinical parameters and patients' comfort. Several studies have demonstrated the interest of the measurement of the work of breathing (WOB) to optimize the settings of NRS in children, but no study has already demonstrated the utility of WOB to optimize the settings of NRS in preterm infants. Therefore, the aim of this study is to measure the WOB during the utilisation of three different NRS (CPAP, HFNC, O2), in order to optimize the choice of the type and settings of NRS in a randomized group of 30 newborns born prematurely before 30 gestational weeks and still requiring NRS at 29 post conceptual weeks. Moreover, the investigators will compare in the newborns with the optimized NRS by WOB vs. a standard care control group (NRS type and settings determined as clinical routine): 1) the respiratory morbidity and mortality one month after the initial assessment, and at the time of hospital discharge (or transfer) or at 36 weeks of age corrected (whatever comes first), 2) the weaning time of the NRS, 3) the incidence and severity of broncho-pulmonary dysplasia (BPD) at 36 weeks of age corrected. Indeed, incidence of BPD is still around 40% in premature infants born before 28 gestational weeks. The hypothesis of the investigators' study is that the optimization of the type and settings of the NRS could reduce the weaning delay and contribute to reduce the incidence and severity of BPD in premature newborns.

NCT ID: NCT03512158 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Non-invasive Respiratory Support in Preterm Infants

NOVEL
Start date: May 15, 2018
Phase: N/A
Study type: Interventional

Lungs of babies born early are not fully developed and they often need a machine to help them breathe. The traditional approach to provide this support is with a breathing tube passed into the windpipe. However, we know that breathing tubes can cause injury to the fragile lungs of premature babies. Providing breathing support through nose-masks instead of breathing tubes (called nasal breathing support) is becoming popular, as it is gentler on developing lungs. Doctors, in trying to limit the use of support with a breathing tube, are using many different forms of nasal breathing support. The most common form is nasal continuous positive airway pressure (CPAP) which delivers a constant pressure and the baby breathes on his on her own. However, when this strategy is no longer able to support a premature baby's breathing, the best way to provide breathing support is not known. Some doctors use a strategy called "nasal intermittent positive airway pressure" (NIPPV) which gives the baby artificial breaths through the nose-mask. Others simply increase the pressure on nasal CPAP to higher than traditional levels. In the first study of its kind, we will compare these two strategies of nasal breathing support given to premature babies.

NCT ID: NCT03373721 Recruiting - Preterm Infant Clinical Trials

Gut Microbiota of Preterm Infants and Full-term Infants at Early Life

Start date: July 20, 2014
Phase:
Study type: Observational

The aim of this study is to obtain a longitudinal view of the gut microbial establishment of a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90 days of age, and to identify key clinical factors that affect the establishment of neonatal microbiome. The hypothesis of the investigators is that the gut microbiota progression of PT group and FT group is different in diversity and composition. Antibiotics and its usage duration is likely the main factor disturbing the colonization and development of the gut microbiome of PT infants.