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Premature Birth clinical trials

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NCT ID: NCT04342585 Completed - Preterm Birth Clinical Trials

Comparison Between Vaginal Pessary and Progestogen in Twin Pregnancy With Short Cervical Length

Start date: October 1, 2019
Phase: Phase 3
Study type: Interventional

A randomized clinical trial comparing vaginal progestogen and vaginal pessary as an intervention for twin pregnancies with short cervical length.

NCT ID: NCT04342078 Active, not recruiting - Lung Diseases Clinical Trials

Vitamin D and Health Outcomes in Preterm Born Population

ViDePrePop
Start date: September 1, 2018
Phase:
Study type: Observational

Improved survival of very preterm newborn population during the last decades has challenged us neonatologists to study and improve nutritional practices including vitamin D (VitD) supplementation. However, long term outcome in this aspect has not been researched in well documented preterm populations. As VitD has receptors in almost all human cells it modulates growth of many organs. Therefore I start to assess VitD supplementation practices and later health outcome (bones, teeth, muscles, heart, lungs) in two preterm population cohorts cared in Oulu University Hospital at the age of 5 years and 24 years (born 2014-2017 and 1994-1997).

NCT ID: NCT04337476 Completed - Music Therapy Clinical Trials

The Effects of Pacifier Activated Lullaby in VLBW Preterm Infants

PAL
Start date: April 30, 2020
Phase: N/A
Study type: Interventional

Music and music therapy, live or recorded, has been introduced in the Neonatal Intensive Care Unit (NICU) of the Del Ponte hospital in Varese in addition to standard medical and nursing care, to improve premature neonates' neurophysiological development. Recent studies focused on the effects of the maternal voice or the entrained singing and live music, highlighting their benefits on neonates stress, on not-nutritive sucking and on the caloric intake. Aim of our study is to evaluate the effect of parents singing or musictherapist singing admistered by Pacifier Activated Lullaby (PAL) on infant's behavior and nutritional outcomes. Particularly, we will evaluate infants' Heart Rate Variability during music therapy session, exclusive oral feeding achievement, weigth increase and hospitalization in a group of preterm infants administered to PAL compared with a control group of preterm infants not exposed to PAL stimulus.

NCT ID: NCT04335240 Recruiting - Music Therapy Clinical Trials

Premature Family Music Therapy Intervention (PFMI)

PFMI
Start date: April 30, 2021
Phase: N/A
Study type: Interventional

The music therapy intervention it is dedicated to premature baby and their family at the Neonatal Intensive Care Unit (NICU)of the Woman-Child department "Hospital Del Ponte". In NICU an integrated psychological and music therapeutic protocol has been structured. The protocol aims to limit or overcome long-term developmental morbidities, promote parenting and attachment bond in preterm infants. Protocol is named "Premature family music therapy intervention (PFMI): an Italian protocol to support parenting, attachment bond and preterm development". The methodologies will provide early intervention from the first days of hospitalization in NICU and use music therapy sessions "active" (chant parental, live music and lullaby) and "receptive" (listening to recorded tracks). Such therapy becomes a support for the born prematurely and her parents during hospitalization and after discharge. The music therapy accompanies the newborn and his parents during the hospitalization and focuses its attention on the emotional-relational care, according to the different needs of babies and parents. This protocol it is a Family Centered Care Music Therapy Intervention.

NCT ID: NCT04333563 Completed - Premature Birth Clinical Trials

Non-invasive Neurally Adjusted Ventilator Assist or Continuous Positive Airway Pressure in Preterm Infants

Start date: April 14, 2020
Phase: N/A
Study type: Interventional

Strategies to prevent lung injury, facilitate lung development, and to support the preterm infant's capacity to breathe are decisive. Continuous positive airway pressure (CPAP) is the gold standard in non-invasive breathing support in preterm infants with a positive pressure that keeps the alveoli slightly inflated during expiration. Non-invasive neurally adjusted ventilator assist (NIV NAVA) is a novel method of breathing support and uses the electrical activity from the diaphragm to trigger the ventilator and synchronize with the breathing cycle. During NIV NAVA the preterm infant controls the onset of the inspiration, the respiratory rate, inspiratory time and peak pressure. This method has the potential to improve the positive pressure transmission to the infant's lower airways, accurate synchronization with the breathing pattern and be a comfortable breathing support system for the preterm infant. The investigators will compare the effect on breathing effort in preterm infants during continuous positive airway pressure and non-invasive neurally adjusted ventilatory assist measured by electrical activity in the diaphragm, respiratory vital signs, systematic clinical scoring of breathing effort and comfort, and parent reported outcomes.

NCT ID: NCT04333121 Not yet recruiting - Pre-Term Clinical Trials

Modelling Weight Reference Centiles for Preterm Infants

Start date: December 1, 2020
Phase:
Study type: Observational

The aim of this study is to model longitudinal data at NICU of Assuit University Children Hospital to create predictive growth charts for weight in preterm infants from birth till discharge, that take into account the differing growth rates post-birth when compared to in-utero growth ,and to compare it with WHO chart for preterms.

NCT ID: NCT04330859 Completed - Cerebral Palsy Clinical Trials

NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy

Start date: May 25, 2019
Phase: N/A
Study type: Interventional

The goal of this project is to investigate the acceptability, feasibility and fidelity of an innovative NICU rehabilitation program that will include six multimodal, gestational age (GA) appropriate, parent-administered interventions (vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy). Using the general movement assessment (GMA) instrument, the investigators will determine the effects of this program on short-term motor outcomes (general movements (GMs), cranial nerves, posture, movements, tone, and reflexes) in premature infants (≤32 week's gestation and/or ≤1500 grams birthweight) identified as at-risk for CP. The short-term motor outcomes will be measured using the GMA, the Test of Infant Motor Performance (TIMP) and the Hammersmith Infant Neurological Examination (HINE) instruments. This novel program will be applied during the neonatal intensive care unit (NICU) hospitalization when the brain is highly plastic and actively developing with the goal to mitigate severity of brain injury and its impact on development.

NCT ID: NCT04318470 Completed - Clinical trials for Preterm Rupture of Membranes

Identification of Microbial DNA in Maternal Plasma After PPROM

Start date: February 12, 2020
Phase:
Study type: Observational

This study evaluates the use of metagenomic next generation sequencing in identifying microbial DNA in plasma samples of patients with preterm premature rupture of membranes.

NCT ID: NCT04315636 Completed - Preterm Birth Clinical Trials

Surfactant Nebulization for the Early Aeration of the Preterm Lung

SUNSET
Start date: March 19, 2021
Phase: Phase 3
Study type: Interventional

Respiratory distress syndrome is the most common cause of respiratory failure in preterm infants. Treatment consists of respiratory support and exogenous surfactant administration. Commonly, surfactant is administered via an endotracheal tube during mechanical ventilation. However, mechanical ventilation is considered an important risk factor for developing bronchopulmonary dysplasia. Surfactant nebulisation during noninvasive ventilation may offer an alternative method for surfactant administration and has been shown to be promising in terms of physiological as well as clinical changes. In preterm infants with respiratory distress syndrome, the effect of intratracheally administered surfactant on lung function during invasive ventilation has been studied extensively. However, the effect of early postnatal surfactant nebulization remains unclear. Therefore, the investigators plan to conduct a randomized controlled trial in order to investigate the effect of surfactant nebulization immediately after birth on early postnatal lung volume and short-term respiratory stability.

NCT ID: NCT04315428 Completed - Premature Newborn Clinical Trials

Study of Swaddling on Tactile Learning in Premature Infants

EMMASENS
Start date: December 12, 2018
Phase:
Study type: Observational [Patient Registry]

Explore the sensorially of the premature newborn that is fundamental to adapting the care environment to these hospitalized babies