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Premature Birth clinical trials

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NCT ID: NCT01747603 Active, not recruiting - Preterm Birth Clinical Trials

The GROWNDUP Study of Late Preterm Births

GROWNDUP
Start date: May 2013
Phase: N/A
Study type: Interventional

This pilot study will examine the feasibility of conducting a large randomized clinical trial (RCT) to examine the role of a novel, specialized follow-up clinic in preventing complications among late preterm infants (LPTB), born between 34 and 36 weeks gestational age. 1) Study Process: Success will be achieved if 80% of a target population of 100 subjects is met within the first 6 months of recruitment being initiated. 2) Study Resources: Success will be achieved if 80% of follow up appointments are scheduled in a timely manner and if specialized LPTB physicians in the intervention complete assessments 75% of the time in the allocated time frame and 3) Scientific: 95% data completeness on data collection forms will be identified as success A specialized LPTB follow-up clinic is innovative as no studies have evaluated such a programme and standardized follow-up and guidelines for the care of LPTB infants after discharge from hospital do not exist. Until recently, the incorrect assumption has been that these infants are healthy and have limited risks compared to term infants. The study's main question, in addition to assessing the feasibility of this pilot, is: "Do differences exist in short-tem clinical and developmental outcomes among LPTB infants enrolled in an RCT who are randomized to a specialized LPTB follow-up programme when compared to infants randomized to current pragmatic management?" A RCT will provide evidence for the development of guidelines for the follow-up of LPTB infants in the first 6 months of life to reduce complications, readmissions and developmental problems. The results of this study can be generalized to tertiary care and community hospitals and the general population.

NCT ID: NCT01632475 Active, not recruiting - Clinical trials for Bronchopulmonary Dysplasia

Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia

Start date: September 2011
Phase:
Study type: Observational

This is a long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD.

NCT ID: NCT01493063 Active, not recruiting - Clinical trials for Prematurity of Fetus

LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns

Start date: October 25, 2011
Phase:
Study type: Observational

The aim of the study is to estimate the impact of the protein content of breastmilk at the end of hospitalization of the preterm newborn, on the neurodevelopment at 2 years old. The investigators expect a difference of at least 5 points of Development Quotient (DQ) when comparing extreme terciles of the protein content of breastmilk at the end of hospitalization.

NCT ID: NCT01487187 Active, not recruiting - Preterm Infants Clinical Trials

The Effect of Cord Milking on Hemodynamic Status of Preterm Infants

Start date: November 2011
Phase: N/A
Study type: Interventional

Very preterm babies frequently develop problems with their blood circulation during the first few days after birth. These circulation problems could affect the oxygen and blood flow to their brain and lead to effects such as bleeding in the head or delayed developmental milestones later in life. Currently the care for such problems may include transfusion of intravenous fluids or blood to the baby and/or giving the baby medications that can help circulation. The current practice at the delivery of these babies is to immediately clamp their umbilical cords after birth. Recent research studies have shown that giving more of the baby's own blood to them at birth by delayed cord clamping (waiting for clamping the cord for about 30-90 seconds) or by milking the cord, may reduce the number of blood transfusions that these babies may need later on. It may also improve their initial blood pressure and reduce the chances of bleeding in their heads. More research is needed to prove if either delayed cord clamping or milking the cord at birth will be better in terms of improving these babies' health. The aim of this study is to find out if adding some blood to these babies' circulation, through milking the cord at birth, could prevent or reduce the possible problems with blood circulation and the reduced blood flow to the brain that some of these babies may have after birth. The investigators will also investigate if milking the cord at birth could improve their long-term developmental outcome. Hypothesis: In preterm infants less than 31 weeks' gestation, milking the umbilical cord 3 times prior to clamping, compared to immediate clamping after birth will improve systemic blood flow (as assessed by improving superior vena cava flow measured by heart ultrasound in the first 24 hours after birth)

NCT ID: NCT01483079 Active, not recruiting - Prematurity Clinical Trials

Post-Discharge Growth of Infants Who Received Donor Human Milk Products in the Neonatal Intensive Care Unit (NICU)

NICU
Start date: December 2011
Phase:
Study type: Observational

Human milk feeding is associated with great benefits to the health and development of infants, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant. The use of donor human milk products for very low birth weight infants as an alternative to cow milk has risen dramatically in the past year. Purpose: To evaluate post-discharge growth and neurodevelopment of infants less than or equal to 1250 grams birth weight receiving an exclusive human milk protein diet.

NCT ID: NCT01009723 Active, not recruiting - Preterm Delivery Clinical Trials

Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers

Start date: March 2010
Phase: N/A
Study type: Observational

This protocol seeks to longitudinally collect blood samples from a cohort of pregnant women. The biological specimens will be used to determine the predictive power of biochemical markers routinely used in Down syndrome screening in the assessment of patient's risk of preterm delivery.

NCT ID: NCT00831168 Active, not recruiting - Premature Babies Clinical Trials

BEADI - The Bliss Cluster Randomised Control Trial on the Effects of Active Dissemination of Information (BEADI)

BEADI
Start date: October 2005
Phase: Phase 1/Phase 2
Study type: Interventional

BEADI is a dissemination trial, on standards of care of premature babies. The main objective of BEADI is to assess whether an innovative 'active' strategy for the dissemination of neonatal information (evidence reviews, interactive training workshop, benchmarking and feedback, and ongoing support) is more likely to lead to changes in policy and practice than the traditional (more passive) forms of dissemination in English neonatal units. BEADI will focus on three areas of neonatal care for premature (22+0 to 26+6 weeks' gestation) babies born in England: timing of surfactant therapy, staffing for resuscitation at delivery, and temperature control (in line with the main Project 27/28 findings ). However, the approach is applicable to a wide variety of clinical policies and practice. The BEADI study has been granted ethical approval by MREC to use a subset of data collected by EPICure2 up until 31st December 2006 (pre-intervention data). For the post-intervention data, ethical approval has been granted for CEMACH to continue data collection against the three clinical areas using a subset of data items captured in the PN:E2 form, for the three month period between 1st January - 31st March 2007. Local research and development departments of each trust have also been contacted.

NCT ID: NCT00622726 Active, not recruiting - Clinical trials for Retinopathy of Prematurity

Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity

BEAT-ROP
Start date: March 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine the efficacy and additional advantages of intravitreal bevacizumab in the treatment of ROP for both Zone I and Zone II Posterior.

NCT ID: NCT00613210 Active, not recruiting - Healthy Clinical Trials

Sonographic Prediction of Preterm Delivery Between 24-34 Weeks of Gestation

Start date: January 2008
Phase: N/A
Study type: Observational

to evaluate if sonographic measure of short uterin cervix, sludge in amniotic fluid and abnormal doppler of the uterin artery can predict preterm labor

NCT ID: NCT00516334 Active, not recruiting - Cerebral Palsy Clinical Trials

Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns

BrainZ
Start date: May 2006
Phase: N/A
Study type: Observational

This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.