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Premature Infant clinical trials

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NCT ID: NCT06458582 Completed - Premature; Infant Clinical Trials

High Flow Nasal Cannula Is Appropriate Alternative for Stabilization of Very Premature Infants: A Prospective Observational Study

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

A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize very preterm infants immediately after birth. Following placental transfusion, high flow nasal cannula at 8 l/min is administered along with intermittent tactile stimulation. Criteria for switching to other interventions like continuous positive airway pressure or positive pressure ventilation are set for cases of persistent bradycardia or low SpO2.

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: 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: NCT06226051 Not yet recruiting - Premature Birth Clinical Trials

Growing Little PEAPODS Study

Start date: June 2024
Phase:
Study type: Observational

The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth and development. Participants will: - have body growth measurements collected using the PEAPOD device - have nutritional information collected, and - be followed for neurodevelopmental outcomes Participants can expect to be in the study for 36 months.

NCT ID: NCT06212427 Recruiting - Premature Infant Clinical Trials

Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)

Start date: November 20, 2023
Phase: N/A
Study type: Interventional

The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose [2'FL] and lacto-N-neotetraose [LNnT], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting.

NCT ID: NCT05647005 Completed - Premature Infant Clinical Trials

The Effect of Classical and Harp Music Practice on Premature Infants

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

Aim of the study is to determine the effects of classical and harp music practice on physiological parameters (heart rate, respiratory rate and oxygen saturation value), cerebral oxygenation value (rSO2) and comfort of premature infants. It is a parallel, three-group randomized controlled trial with a prospective, pretest, posttest experimental design. The study will be carried out in Selcuk University Medical Faculty Hospital Neonatal Intensive Care Unit (NICU). A total of 84 premature babies will be included in the study, including the group to be listened to classical music (n=28), the group to be listened to harp music (n=28), and the control group (n=28). Triple blocks were created in the computer environment so that the premature infants to be included in the study could be assigned to three study groups using the balanced block randomization method (randomization.com). The randomization will be hidden from the researcher conducting the trial until the administration begins. The researcher will be given 84 envelopes and will begin to open the envelopes when they meet the baby. The researcher will learn which group each baby is in just before the application. Data collection tools; newborn Descriptive Information Form, physiological parameter and rSO2 follow-up form, and Premature infant comfort scale. The rSO2 value will be measured with the NIRS monitor. During the data collection phase, the purpose of the study will be explained to the parents of the premature infants by the researcher first, and informed about the study and consent will be obtained from the parents who agreed to participate in the study through the "Informed Voluntary Consent Form". To venture groups (classical and harp music); After feeding, a music box and a decibel meter will be placed in the incubator and classical music will be turned on at 50-55 dB. Just before the music is played, the premature infants physiological parameters, rSO2 and comfort level will be evaluated and recorded. For 30 minutes, music will be played to the baby according to the intervention group (classical and harp music). After 30 minutes, the baby's physiological parameters, rSO2 and comfort level will be evaluated and recorded again. Each session will be held in this way, a total of 15 sessions of music will be applied to thepremature infants, and the baby's physiological parameters, rSO2 and comfort level will be evaluated and recorded before and after each session. The control group is; premature infants in this group are those who take the clinical routine without being exposed to any music. After feeding, the baby's physiological parameters, rSO2 and comfort level will be evaluated and recorded. They will not be exposed to any music and sound for 30 minutes and there will be no intervention. At the 30th minute, the premature infants physiological parameters, rSO2 and comfort level will be evaluated and recorded. Evaluation of the data will be done in the computer environment with the SPSS (Statistical Package for Social Sciences) 22.0 package program. Partial eta squared will be calculated for the effect size and the significance level will be accepted as p<0.05.

NCT ID: NCT05557435 Not yet recruiting - Pain Clinical Trials

The Effect of Breast Milk Odor on Pain Response and Salivary Cortisol Level in Preterm Infants

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

The aims of this randomized controlled trial are investigate the effects of breast milk odor on pain response and saliva cortisol level duration heel stick blood sampling in preterm infants. Partipants will randomly assigned into the experimental group (breast milk odor) or control group (distilled water odor). The Premature Infant Pain Profile-Revised (PIPP-R) and Salimetrics® Cortisol Enzyme Immunoassay Kit are used to measuring the pain response and saliva cortisol level.

NCT ID: NCT05543005 Not yet recruiting - Premature Infant Clinical Trials

Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants

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

The study aims to evaluate the impact on the preterm infants' short-term physiological, neurodevelopmental states by employing maternal voice intervention in NICU routine care. This study also evaluates the correlation between effective intervention and maternal depression by employing Edinburgh Postnatal Depression Scale .

NCT ID: NCT05430256 Recruiting - Premature Infant Clinical Trials

The Early Life Clinical Feature and Risk Factors Analysis in Children With Neurodevelopmental Disorders

Start date: April 29, 2019
Phase:
Study type: Observational

The study will be a 5-year retrospective and prospective case control study, included 650 participants, and participants will be divided into four groups.By this research the investigators will achieve several aims:(1) Through the cross-sectional analysis of this study, the investigators can understand the current prevalence of developmental disorders in Taiwan ,especially ADHD and ASD, and the ratio of male to female in school-age children. (2) Analysis of risk factors in preterm infants during pregnancy and infant, and construct the diagnostic predictive models. (3) By the cohort study of premature infants, to analyze early risk factors of premature children with neurological developmental disorders (such as ADHD), and develop the diagnostic predictive models and early interventional tools. (4) Using artificial intelligence and machine learning analysis to analyze the characteristics of preterm and development of diagnostic prediction model of premature infant or premature children combined ADHD. (5) The application of noninvasive physiological signal capture real-time analysis system in screening and evaluation of "premature infant and neurodevelopmental disorders".

NCT ID: NCT05410639 Completed - Premature Infant Clinical Trials

Effect of Online Education Given to Parent on Motor Social Development for The Premature Babies in The Neonatal Intensive Care Unites

Start date: February 24, 2021
Phase: N/A
Study type: Interventional

Our study aim to evaluate the effect of online program that provides education to parents of premature infants in which stayed in the neonatal intensive care units (NICU),in their motor,socail-communişcation development and the parents stress level.