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Premature Birth clinical trials

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NCT ID: NCT06327152 Recruiting - Clinical trials for Apnea of Prematurity

Caffeine Use in the Management of Preterm Infants

Start date: February 22, 2024
Phase: Phase 2
Study type: Interventional

This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.

NCT ID: NCT06320587 Recruiting - Premature Infant Clinical Trials

The Effect of Kangaroo Care on Parents' Perceived Parenting Self-Efficacy, Infant Attachment and Newborn Vital Signs

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

This study was planned to determine the effect of kangaroo care applied by parents of premature newborns in the neonatal intensive care unit on the newborn's vital signs, perceived parenting self-efficacy level and attachment to the baby.

NCT ID: NCT06315556 Recruiting - Clinical trials for Retinopathy of Prematurity

An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)

Start date: March 5, 2024
Phase:
Study type: Observational

This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected and studied. ROP is a condition that affects the eyes of preterm babies. It occurs when the baby's retina, the part of the eye that senses light, does not develop normally. This may result in vision problems, including blindness, if left untreated. Preterm babies are born before 37 weeks of pregnancy. ROP is more likely to develop in babies who are born before 32 weeks of pregnancy or weigh less than 1.5 kilograms at birth. Aflibercept is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth of blood vessels in the retina. Aflibercept in PFS given using a PDD is approved for the treatment of babies with ROP. The prefilled syringe will be fitted with an injection needle to give aflibercept. And a PDD is a tool used to give the right amount of aflibercept to children in a safe manner. Since there are other treatments which are commonly used for babies with ROP, the extent of use of aflibercept given using a PDD is unknown. The main purpose of this study is to: - find the number of preterm babies who are treated with aflibercept using a PDD in the UK - inform whether this number is enough to perform a study to learn about the long-term safety of aflibercept given using a PDD in babies with ROP An additional purpose of this study is to describe characteristics including age, sex, and race, and signs and symptoms of ROP observed in babies being treated with aflibercept using a PDD. The data will come from a database called the National Neonatal Research Database. The study will cover the period from March 2024 to March 2025, if the number of babies found is enough to perform the safety study. If not, data will be collected till April 2027. In this study only available data from preterm babies born during the study period are collected. No visits or tests are required as part of this study.

NCT ID: NCT06315452 Active, not recruiting - Clinical trials for Vitamin D Deficiency

FREQUENCY OF VITAMIN D DEFICIENCY IN PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g

PremaVitaD
Start date: February 1, 2022
Phase:
Study type: Observational

Vitamin D plays an important role in phosphocalcic metabolism and bone homeostasis in newborns. Premature newborns are at risk of vitamin D deficiency and may require supplementation. In this context, the French Society of Pediatrics (Société Française de Pédiatrie) recommends systematic vitamin D testing at 1 month. The aim of this study was to determine the frequency of vitamin D deficiency in premature newborns.

NCT ID: NCT06308991 Completed - Clinical trials for Endotracheal Aspiration

Effect of Touch Methods in Preterm Infants During Endotracheal Aspiration

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study was to determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants.

NCT ID: NCT06308471 Completed - Infant, Premature Clinical Trials

Effect of Baby Massage on Oral Motor Skills of Premature Babies

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

This experimental research was conducted in a single-blind, block randomized controlled design type. The primary purpose of the study is to examine the effect of premature baby massage on oral motor coordination skills. The secondary aim is to evaluate the consistency of use of The Oral Feeding clinical scale in premature babies in Turkey. As a result of the power analysis, baby massage was applied to the intervention group (n = 20) and oral stimulation with the Fucile protocol was applied to the control group (n = 20). Comparative results were evaluated statistically.

NCT ID: NCT06306794 Not yet recruiting - Pain Clinical Trials

Reducing Pain Levels and Increasing Comfort of Premature Infants During Aspiration

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

The aim of this study was to investigate the effect of using amigurumi octopus on the pain and comfort of the newborn in premature infants undergoing endotracheal aspiration. It is a randomized controlled quasi-experimental design. The study will be conducted in the neonatal intensive care unit of Health Sciences University Bursa High Specialization Training and Research Hospital. The population of the study will consist of preterm hospitalized in the neonatal intensive care unit during the period of the conducted study. In the calculation of the sample size, the power level is 80% and the significance level is 5%. It was determined by the statistical expert that the number of babies that should be included for each group is 26 and the total number of babies required for the whole study is 52 when the effect size is determined as 0.8 for the investigation of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable. Based on aforementioned information, the study sample was determined as 80 preterm infants in which 40 for experimental groups and 40 for control groups. Block randomization method will be applied for the randomization of the groups. PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used as a case report form for the collection of the study data. All the patients included in the study will be intervened by the nurse having a neonatal nursing experience by paying attention to aseptic conditions in accordance with the routine aspiration criteria of the unit. Standardization will be ensured by intervening in all patients with the same application by the same nurse. During the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure. Babies will be allowed to touch the octopus for 10 minutes during and after the procedure. Physiologic parameters of the infants before, during and after the procedure will be reported and recorded by camera. According to the video recordings, PIPP-R and PICS scale evaluations of the infants will be made by two research nurses other than the main researcher conducting the study. The routine aspiration application steps of the unit will be applied to the control group without any intervention.

NCT ID: NCT06305052 Active, not recruiting - Premature Birth Clinical Trials

Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies

Start date: April 4, 2023
Phase: N/A
Study type: Interventional

The objective of this clinical trial is to test the effects of olfactory and taste stimulation with milk or water in premature newborns with a gestational age between 28 and 32 weeks. The main question researchers want to resolve is: • Does olfactory and gustatory stimulation in these newborns reduce the time spent with an oral or nasogastric feeding tube and bring forward oral feeding? Participants will be stimulated with milk or water depending on the randomly chosen group. 1: the olfactory stimulus (with smell) will be performed with a sterile cotton swab close to the nostrils immediately before feeding through the tube, 2: the gustatory stimulus (taste) will be performed with a sterile cotton swab on which a drop of milk or water will be applied on the newborn's tongue if they are awake or on their lips if they are sleeping, and is performed immediately before tube feeding.

NCT ID: NCT06302543 Recruiting - Clinical trials for Premature Ovarian Insufficiency

Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells

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

investigator is doing single armed clinical interventional study to treat premature ovarian insufficiency with autologous bone marrow derived mononuclear cells to be given systematically and locally to the ovaries under ultrasound guidance with experienced gynecologist and to look for the results including: laboratory evidence through hormonal study ultrasound proof of ovarian follicle development. premature ovarian insufficiency is characterized by early loss of ovarian function (less than 40 years of age) manifested by menstrual irregularity or amenorrhea with elevated levels of gonadotropin hormones and low estrogen and anti-Mullerian hormone. Autologous use of stem cells from bone marrow are alternative safe minimal manipulative products that can provide a solution to this clinical problem without the need for oocyte donation program.

NCT ID: NCT06302023 Not yet recruiting - Clinical trials for Pregnant Women Diagnosed With Threatened Preterm Labor

Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor

Start date: March 1, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to learn about the effects of Docosahexaenoic acid (DHA) in reducing the incidence of premature birth in threatened preterm labor The main questions it aims to answer are: - Can DHA supplementation reduce the incidence of premature birth in threatened preterm labor? - How does DHA supplementation affect pregnancy outcomes? Participants were organized into two groups - Group 1 (Intervention) Participants will be asked to take a DHA 1000mg per day - Group 2 (control) Participant will not need to take a DHA