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Premature Birth clinical trials

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NCT ID: NCT04295564 Active, not recruiting - Premature Birth Clinical Trials

Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function

Start date: January 10, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing.

NCT ID: NCT04193579 Active, not recruiting - Premature Birth Clinical Trials

Listening to Mom 2: Neural, Clinical and Language Outcomes

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

The purpose of this study is to examine whether playing recordings of a mother's voice to her infant while in the hospital nursery is an effective treatment for promoting healthy brain and language development in infants born preterm.

NCT ID: NCT04184648 Active, not recruiting - Clinical trials for Bronchopulmonary Dysplasia

Comparison of Classification Standards of BPD in Premature Infants

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

Bronchopulmonary dysplasia of premature infants is a common respiratory disease in premature infants. Long-term complications such as recurrent respiratory infection and abnormal lung function may occur in the survivors, and may increase the risk of dysplasia of the nervous system. In the past 30 years, although the monitoring and treatment technology of premature infants has been significantly improved, the incidence of BPD still shows no downward trend, and effective treatment and prevention methods for BPD are still lacking. The progress of clinical research on BPD is slow, one of the important reasons is that the definition of BPD is still not consistent, and its diagnostic and grading standards lack objectivity. To summarize the development of diagnostic criteria for BPD in the past 30 years, there are still the following disadvantages. 1. 2. In the above study, all proposed alternative BPD classification standards did not completely separate HFNC and NIV. In view of this, this study separated HFNC and other NIV to form a new revised BPD classification standard. On this basis, a nested case-control study was conducted to compare the differences between the newly proposed classification standards and NICHD standards in 2001, Rosemary standards in 2018 and Jensen standards in predicting long-term respiratory outcomes and other systemic complications in premature infants, so as to provide a standard for more accurate diagnosis and evaluation of BPD in premature infants.

NCT ID: NCT04015180 Active, not recruiting - Clinical trials for Retinopathy of Prematurity (ROP)

Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090

FIREFLEYE next
Start date: March 18, 2020
Phase: Phase 3
Study type: Interventional

This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.

NCT ID: NCT03928457 Active, not recruiting - Preterm Infant Clinical Trials

Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate

NeuroPrem-RF
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The massive use of highly technological devices in Neonatal Intensive Care Units may expose preterm neonates to electromagnetic fields, especially radiofrequencies, at low doses but continuously and chronically. Strikingly, the effect of long-term exposure to radiofrequencies on the neurophysiological development of preterm neonates has never been studied so far. The only studies on the impact of chronic exposure to radiofrequencies have been conducted in animals or adult humans, whereas preterm infants may be particularly vulnerable due to increased penetration of radiofrequency waves into the brain during a crucial period of neurodevelopment. The present project will aim at 1) quantifying individual levels of chronic exposure (during 6 weeks) to which preterm neonates are subjected during their stay in the Neonatal Intensive Care Unit, 2) following the evolution of the thermal environment and of the clinical parameters of the neonates after birth, 3) identifying potential alterations of neurophysiological activity (sleep, cerebral hemodynamics, autonomic nervous activity) which will be correlated to actual levels of chronic RF-EMF (radiofrequency electromagnetic fields) exposure.

NCT ID: NCT03906708 Active, not recruiting - Premature Lungs Clinical Trials

Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature

P3
Start date: January 1, 2019
Phase:
Study type: Observational

The purpose of this study is to examine if infants are more likely to suffer from respiratory complications during their first year of life due to being born premature.

NCT ID: NCT03814395 Active, not recruiting - Obesity Clinical Trials

Peking University Birth Cohort in Tongzhou

PKUBC-T
Start date: June 28, 2018
Phase:
Study type: Observational

The PKUBC-T is a prospective cohort study carried out in Tongzhou district of Beijing, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to 6 years old. Biological samples including blood and tissue samples are also collected from mothers and their children.

NCT ID: NCT03808051 Active, not recruiting - Preterm Infant Clinical Trials

Aeration, Breathing, Clamping Study 3

ABC3
Start date: January 25, 2019
Phase: N/A
Study type: Interventional

Delayed cord clamping (DCC) in preterm infants results in a decrease in mortality and a trend towards fewer intraventricular haemorrhages. However, preterm infants needing immediate interventions for stabilisation or resuscitation were generally clamped immediately and excluded from trials, while these infants might benefit the most of DCC. Studies in preterm lambs demonstrated that delaying cord clamping beyond ventilation onset resulted in more stable hemodynamic transition. This approach was called 'physiological-based cord clamping' (PBCC). The hypothesis of this study is that PBCC in preterm infants at birth will lead to an increase in intact survival when compared to standard care. This study is a multicentre randomised controlled, parallel design, superiority trial, including preterm infants less than 30 weeks of gestation. The intervention is PBCC: stabilisation of the infant with the umbilical cord intact and only clamp the cord when the infant is stable. Stable is defined as the establishment of heart rate greater than 100 bpm and oxygen saturation above 85% while using supplemental oxygen lower than 40%. In the control group cord clamping will be performed time-based: infants are clamped first (at 30-60 seconds if the clinical condition allows) and then moved to the resuscitation table for further stabilisation. The primary outcome will be intact survival at NICU discharge, defined as survival without cerebral injury (intraventricular haemorrhage ≥ grade 2 and/or periventricular leukomalacia ≥ grade 2 and/or periventricular venous infarction) and/or necrotizing enterocolitis (Bell stage ≥ 2).

NCT ID: NCT03714633 Active, not recruiting - Extreme Prematurity Clinical Trials

Stockholm Preterm Interaction-Based Intervention

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

Extreme premature Children will at discharge from Karolinska Hospital and Södersjukhuset in Stockholm be asked to participate in a study, examining the effects of a home-visit based post-discharge program aiming at facilitating the interaction between infants and parents, improving the development of the children, and the parental mental health. The study is a randomized controlled Trial (RCT), hence 50% of the participants will be offered treatment as usual (TAU) with addition of an extended follow-up program. The interaction-based program consists of one initial visit at the hospital followed by nine home-visits and two telephone calls during the child's first year of life. The interventionists are skilled Healthcare professionals with several years of experience from caring for premature infants and their parents. All interventionists have successfully completed a one year further education program, delivered one day per week and containing theoretical lectures, practice with actual cases, supervision on the cases, visits to the different parts of the neonatal care chain and discussions with a representative from the premature family association Sweden.

NCT ID: NCT03675425 Active, not recruiting - Clinical trials for Patent Ductus Arteriosus After Premature Birth

The Effects of Phototherapy in Preterm Infants Pda

Start date: July 8, 2018
Phase: N/A
Study type: Interventional

The study was designed to assess whether chest shielding during phototherapy reduces the incidence of PDA, as assessed by serial echocardiographic examinations, in a population of extremely preterm infants born at lower 30 week gestation.