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Premature Birth clinical trials

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NCT ID: NCT06379178 Completed - Preterm Clinical Trials

Effect of Oral Colostrum Applications Every 2 Hours and 4 Hours In Order to Achieve Trophic Feeding in Preterm Infants

Start date: February 19, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is aims to evaluate the effects of applying colostrum orally every 4 and 2 hours in order to achieve trophic feeding in preterm infants. The main question it aims to answer is the optimal frequency of colostrum application that can be applied Participants will be divided by randomization using permutation blocks after meeting the inclusion and exclusion criteria and deemed eligible. These blocks were then randomized using computer software such as Microsoft Excel, determining the sequence for allocation to the control and intervention groups based on the randomization order from the permutation code, every 2 hours and every 4 hours. Researchers will investigate the effects of oropharyngeal colostrum application frequency, every 4 hours and every 2 hours, in order to achieve trophic feeding in preterm infants <34 weeks gestational age.

NCT ID: NCT06377397 Not yet recruiting - Sepsis Clinical Trials

Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates

SAUNA
Start date: April 15, 2024
Phase: Phase 3
Study type: Interventional

Preterm infants are born at less than 37 weeks of pregnancy. Sometimes a break or tear in the fluid filled bag that surrounds and protects the infant during pregnancy leads to an untimely birth. This state puts the infant at risk of serious condition called sepsis. Sepsis is a condition in which body responds inappropriately to an infection. Sepsis may progress to septic shock which can result in the loss of life. Doctors give antibiotics to treat sepsis. The goal of this research study is to find out: 1. Among neonates at risk of early-onset neonatal sepsis, whether a policy of administering antibiotics selectively to a subset of at-risk infants who later develop signs of sepsis is not inferior to administering antibiotics to all at-risk infants in the 1st week of life. 2. To find out if infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) require fewer antibiotic courses of 48 hours duration or more in the 1st week of life. 3. To find out whether infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) are significantly different with respect to a wide range of secondary outcomes (listed under "Outcomes").

NCT ID: NCT06374147 Not yet recruiting - Clinical trials for Apnea of Prematurity

"Prapela® SVS Incubator Pad for Apnea of Prematurity

Prapela AOP
Start date: May 15, 2024
Phase: N/A
Study type: Interventional

The study proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad with stochastic vibrotactile stimulation (SVS) that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Currently, the only approved therapy for AOP is Caffeine Citrate. The SVS mattress pad can prove to be an effective, non-invasive adjunct to Caffeine Citrate for preterm infants with potential to shorten the need for respiratory support as well as overall shortened length of stay.

NCT ID: NCT06371443 Completed - Premature Infant Clinical Trials

Suction and Swalloing Exercises for Premature Babies

Start date: December 3, 2021
Phase:
Study type: Observational

Underdeveloped oral structures of preterm infants cause feeding problems. Therefore, the development of sucking reflexes of premature babies should be supported. This study aimed to investigate the effect of suck-swallow training on the transition to oral feeding in premature infants. The study was conducted as a randomized controlled experimental trial in the NICU of a public hospital in Istanbul. The study sample consisted of 82 premature infants. Of these infants, 41 were assigned to the experimental group and 41 to the control group. Study data were collected using the investigator-developed Premature Infant Data Collection Form and Early Feeding Skills Assessment Tool. Throughout the study, preterm infants in the experimental group (n=41) were given suck-swallow exercises for 12 minutes once a day before feeding for 14 days. SPSS21 was used to analyze the data.

NCT ID: NCT06367881 Recruiting - Preterm Birth Clinical Trials

Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS

Start date: August 18, 2022
Phase: Phase 1
Study type: Interventional

An Exploratory Randomized double-arm controlled trial to evaluate the immunomodulatory effect of low versus high dose of Alveofact with or without Budesonide.

NCT ID: NCT06365164 Not yet recruiting - Premature Clinical Trials

Study of the Emergence of Sensory Self-awareness in Premature Newborns Using the Rooting Reflex

PREMATACT
Start date: June 2024
Phase:
Study type: Observational

The main objective is to demonstrate the presence of the rooting reflex in premature and the emergence of sensory self-awareness in premature by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during quiet wakefulness. The main hypothesis is to confirm the tactile skills of the very premature newborn in exploring the rooting reflex and then to evaluate the emergence of sensory self-awareness. The investigators assume a difference in response in favour of a greater response of the newborn to external tactile stimulation compared to facilitated self-stimulation in favour of the distinction between self and non-self showing the emergence of a sensory awareness of self in the preterm newborn.

NCT ID: NCT06362798 Not yet recruiting - Preterm Birth Clinical Trials

Effect of Support for Low-Income Mothers of Preterm Infants

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist. An important predictor of the long-term consequences of preterm birth is maternal presence during the prolonged infant hospitalization (weeks to months) in the neonatal intensive care unit (NICU). Mothers who visit the NICU can pump breast milk, directly breastfeed and engage in skin-to-skin care, which facilitates breast milk production and promotes infant physiologic stability and neurodevelopment. Low-income mothers face significant barriers to frequent NICU visits, including financial burdens and the psychological impact of financial stress, which hinder their participation in caregiving activities. The investigators will conduct an randomized controlled trial (RCT) to test the effectiveness of financial transfers among 420 Medicaid - eligible mothers with infants 24 - 33 weeks' gestation in four level 3 NICUs: Boston Medical Center (BMC) in Boston, Massachusetts, UMass Memorial Medical Center (UMass) in Worcester, Massachusetts, Baystate Medical Center in Springfield, Massachusetts, and Grady Memorial Hospital in Atlanta, Georgia. Mothers in the intervention arm will receive usual care enhanced with weekly financial transfers and will be informed that these transfers are meant to help them spend more time with their infant in the NICU vs. a control arm (usual care). The primary hypothesis is that financial transfers can enable economically disadvantaged mothers to visit the NICU, reduce the negative psychological impacts of financial distress, and increase maternal caregiving behaviors associated with positive preterm infant health and development.

NCT ID: NCT06362278 Recruiting - Clinical trials for Coronary Artery Disease

A Multi-omics Study of "Healthy" Premature CAD Patients

Start date: March 20, 2024
Phase:
Study type: Observational

The goal of this multi-center observational clinical trial is to investigate the genetic risk factors of patients with premature CAD and none traditional CAD risk factors through a multi-omics approach. The main questions it aims to answer are: - Genetic risk factors & metabolic fingerprints of patients with premature CAD and none traditional CAD risk factors remain unknown. - How to optimize current primary prevention strategy for this rare CAD subgroup?

NCT ID: NCT06359288 Completed - Education Clinical Trials

Preterm Newborn Mothers' Anxiety and Self-Efficacy

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The aim of this study was to evaluate the effect of QR code supported infant care training given to mothers of preterm newborns on maternal self-efficacy and maternal anxiety level .

NCT ID: NCT06359015 Active, not recruiting - Preeclampsia Clinical Trials

Metformin and Esomeprazole in Preterm Pre-eclampsia

Start date: February 11, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to better understand diagnosis and treatment of preterm preeclampsia. Currently, there are limited laboratory tests that can be used to diagnosis preeclampsia. Additionally, there are few treatments for this condition. This clinical trial will explore treatment options, Metformin and Esomeprazole, as well as serum markers that could improve the diagnosis and treatment of preterm preeclampsia.