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Premature Birth clinical trials

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NCT ID: NCT04559061 Completed - Atrial Fibrillation Clinical Trials

Vektor vMap™ Clinical Validation Study

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

This is a retrospective, multi center clinical study collecting existing, de-identified subject data from medical records to be analyzed using an independent core laboratory to validate performance of a computational ECG mapping system (vMap™).

NCT ID: NCT04554745 Completed - Preterm Labor Clinical Trials

The Cervical Length and Thickness of Cesarean Section Scar With Preterm Labor

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Although the Cesarean section is one of the most common obstetric operations around the world, the World Health Organization recognizes that where cesarean rates are higher than 10%, there is no increase in beneficial maternal and newborn outcomes. some researchers noted that in countries where cesarean rates are above 15%, populations experience higher maternal, infant, and neonatal mortality rates. infants born by cesarean delivery are more likely to require neonatal intensive care unit and have greater respiratory complications, and higher odds for childhood asthma, and obesity. Preterm is defined as babies born alive before completing 37 weeks of pregnancy. Preventing Preterm birth is a global priority due to increased risk for neonatal morbidity and mortality.

NCT ID: NCT04539106 Completed - Clinical trials for Retinopathy of Prematurity

Intravitreal Ranibizumab in Recurrent ROP

Start date: June 1, 2019
Phase:
Study type: Observational

A retrospective study included reviewing of medical records of preterm babies who were admitted in neonatal intensive care unit (NICU) of Mansoura University children hospital (MUCH) or referred from nearby hospitals for ROP screening during the period from March 2013 to February 2020.

NCT ID: NCT04537065 Completed - Clinical trials for Retinopathy of Prematurity

Long Term Outcome of Intravitreal Ranibizumab for ROP

Start date: April 1, 2018
Phase:
Study type: Observational

premature infants who had a history of intravitreal injection of (Ranibizumab) not less than one year were examined for refractive state and biometry

NCT ID: NCT04527601 Completed - Covid19 Clinical Trials

Extremely Premature Births During the Peak of the COVID-19 Pandemic: an International Study of the Active SafeBoosC III Departments

Start date: August 21, 2020
Phase:
Study type: Observational

This is a retrospective, observational study based on the consortium of the SafeBoosC-III randomised clinical trial. This study will evaluate if the number of admitted extremely preterm infants has decreased in the SafeBoosC-III departments during the global lockdown, and whether there is an association between the level of lockdown restrictions and change in the number of ELGAN admissions.

NCT ID: NCT04525872 Completed - Premature Birth Clinical Trials

Parenteral Nutrition Light Protection and Premature Outcomes

Start date: July 10, 2020
Phase: N/A
Study type: Interventional

Investigators propose a prospective study to investigate the effect of full light protection of the PN on cholestasis and other oxidative stress associated diseases in premature infants when they receive PN for more than one week. Each infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing. Demographic characteristics, clinical outcomes (incidence of cholestasis, feeding tolerance, BPD, ROP, NEC and mortality) and oxidative stress markers (e.g., carboxyhemeglobin) will be evaluated. Phase one of this study employed a retrospective chart review methodology to evaluate the effect of no PN light protection vs partial PN light protection (PN solution only while it's the tubing and lipids remained exposed to light). Infants from phase one of this study will serve as the controls in the evaluation the effect of full PN light protection on the cholestasis, clinical outcomes and oxidative stress. Investigators propose to collect urine and saliva samples in infants who we expect to receive PN for a minimum of 5 days, on days 0, 3, 5 and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition to evaluate oxidative stress.

NCT ID: NCT04522414 Completed - Preterm Birth Clinical Trials

PremCry Study : Study of Ontogeny of Crying in Preterm Infants.

PremCry
Start date: November 20, 2020
Phase:
Study type: Observational

Crying is a survival mechanism for babies and their almost exclusive means of expression until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger, discomfort or separation following the departure of a parent around. Crying is a complex but essential means of communication and information between a baby and his parents that raises the question of their meaning. Very few longitudinal studies have been produced on preterm's crying. As the term approaches, the characteristics of preterm babies' crying are similar to those of term infants. But these studies date back more than 30 years and are obsolete in terms of the quality and performance of sound recording equipment and signal processing. No study has looked at the genesis of the cry itself and the varieties of the cry of the preterm baby, depending on whether it was in a situation of hunger, pain, discomfort (bath).

NCT ID: NCT04521725 Completed - Prematurity Clinical Trials

Effect of Monitoring Devices on Healthcare Provider Performance During Neonatal Resuscitation

Start date: October 5, 2020
Phase: N/A
Study type: Interventional

Babies born very early (at less than 32 weeks) usually need help to breath right at birth, also called neonatal resuscitation. Healthcare providers (HCPs) are specially trained to provide this help. HCPs uses information about the baby's condition, such heart rate and oxygen levels, to decide whether they giving the baby effective help, or whether other actions are needed. It can be very stressful for even experienced HCPs to interpret all this data, coordinate a team, make decisions, and perform specialized skills all at the same time. More recently, new ways of monitoring how a baby is doing neonatal resuscitation has been studied. Respiratory function monitoring (RFM) is a machine that can measure how much air is going into the lungs. This is important as too much air can lead to lung damage, while too little air means that the baby isn't breathing effectively. Another measure is called cerebral near-infrared spectroscopy (cNIRS), which measures oxygen levels in the brain using a probe placed on the forehead. Providing the right amount of oxygen to the most vulnerable organ - the brain - can be important in lowering the risk for injuries to the brain such as brain bleeding. While these machines give us more information, it can also make it even harder for HCPs to focus on the task, adding more complexity to making decisions, adding to their workload, and causing more stress. To study the effect RFM and cNIRS may have on how affects HCPs workload and stress, the investigators will study HCPs self-reported workload during three time periods - first, doing resuscitations only using basic information (Group 1: heart rate, oxygen levels, direct observations of the baby), second, adding RFM (Group 2), finally adding both RFM and cNIRS (Group 3). A survey called NASA Task Load Index will be used to study HCPs workload. On a small number of teams, the investigators will also track where the leader of the team is looking using eye-tracking glasses, how stressed the leader is by measuring their heart rate, skin sweat, and pupil dilation. Finally, the investigators will collect some information about the baby's resuscitation and hospital stay.

NCT ID: NCT04494529 Completed - Preterm Birth Clinical Trials

Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth

SNACS Pilot
Start date: March 1, 2021
Phase: Phase 3
Study type: Interventional

Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome, in preterm infants. Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone (for a total of 24 mg) to accelerate fetal lung maturity. We plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose (total 12 mg) of betamethasone to the standard double dose (total 24 mg) of betamethasone. The results of this pilot will be combined with the full-scale RCT (NCT05114096) for which we have received funding from the Canadian Institutes of Health Research (CIHR).

NCT ID: NCT04451928 Completed - Preterm Birth Clinical Trials

Prediction of Preterm Delivery by Serum Ischemia Modified Albumin, Biglycan and Decorin Levels in Women With Threatened Preterm Labour

Start date: December 1, 2019
Phase:
Study type: Observational [Patient Registry]

In this study, the levels of ischemia modified albumin, biglycan and decorin in the serums of pregnant women hospitalized for preterm labor will be examined. Their serum levels will be compared between women having preterm and term delivery. Their accuracy will be asessed in predicting preterm birth.