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Newborns clinical trials

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NCT ID: NCT06387888 Completed - Newborns Clinical Trials

The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns

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

This study was conducted in a randomized controlled experimental type to determine the effect of maternal voice during care on pain and comfort level in term newborns receiving mechanical ventilation. The sample of the study was consisted of 60 term newborns receiving mechanical ventilation who were hospitalized in the 7-bed Neonatal Intensive Care Unit of a private hospital in Istanbul in accordance with the selection criteria. Introductory Information Form, Vital Signs Follow-up Form, Neonatal Comfort Behavior Scale and Neonatal Pain Scale (NPASS) forms prepared by the researchers were used as data collection tools.

NCT ID: NCT06350071 Recruiting - Pain, Acute Clinical Trials

Effect of Kangaroo Care and Swaddling Methods on Pain Level and Crying Time During Heel Blood Collection

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

This prospective study is planned as a randomized controlled study with the purpose of determining the effect of kangaroo care and swaddling methods on pain levels and crying times by newborns during heel blood collection.

NCT ID: NCT05705258 Recruiting - Clinical trials for Retinopathy of Prematurity

A Study to Collect Data on the Use of Eylea in Babies Born Too Early Who Have a Condition of the Eye Where Blood Vessels Grow Abnormally in the Retina (Retinopathy of Prematurity)

Start date: March 27, 2023
Phase:
Study type: Observational

This is an observational study to collect data from Japanese babies with retinopathy of prematurity (ROP) who will be treated with Eylea. In observational studies, only observations are made without specified advice or interventions. ROP is a condition that affects the eye and occurs only in babies who are born too early. Most cases of ROP are mild and get better without treatment, but more serious cases need to be treated in time. ROP happens when the blood vessels in the "retina" grow abnormally. The retina is the layer of tissue at the back of the eye that picks up light and sends messages to the brain. In babies with ROP, these abnormal blood vessels can leak. This causes damage to the retina and can sometimes move it out of place causing medical problems such as blindness. Eylea is received as an injection into the eye. It works by blocking a certain protein (VEGF) that can cause blood vessels in the retina to grow abnormally. Eylea is already available in Japan and is approved for doctors to prescribe to babies with ROP. The participants in this study are Japanese babies with ROP that their doctors decided to treat with Eylea before the start of this study. Babies with ROP that were already prescribed Eylea by their doctors may also be included. The main purpose of this study is to collect more data on how safe the treatment with Eylea is in babies with ROP under a real-world setting. Another purpose of this study is to collect more data on how well Eylea works in these participants. To see how safe Eylea is, the study doctors will collect all medical problems that the participants treated with Eylea have. These medical problems are called adverse events. Doctors keep track of all the adverse events that happen, even if they do not think that they might be related to the treatment. To see how well Eylea works, the study doctors will check the number of participants: - with no active ROP after starting treatment - where ROP came back up to 6 months after start of treatment In this study, the study doctor will: - collect past data of the participants from medical records - interview the participants - collect treatment-related data during routine visits. The study duration is 6 months with 3 planned visits. One visit will be at start of treatment, one at one month and one at 6 months after start of treatment. All data required for this study will be collected during routine visits. Besides this data collection, no further tests or examinations are planned in this study.

NCT ID: NCT05476640 Not yet recruiting - Newborns Clinical Trials

Newborn Sequencing Screening in China

Start date: August 5, 2022
Phase:
Study type: Observational

The project will carry out the genetic testing of 10000 neonates. The aim of the project is to assess the application of targeted sequencing technology in the screening of neonatal diseases.

NCT ID: NCT04984967 Recruiting - Intensive Care Clinical Trials

Interest of Peripheral Venous Catheter Insertion Using a Micro-guide in Neonatology

EASYCATH
Start date: December 8, 2021
Phase: N/A
Study type: Interventional

Peripheral venous catheterization represents the preferential option for term or preterm infant care in order to start drug treatment or hydration, or perform anesthesia. However, the peripheral venous access is associated in approximately 50% of cases with a failure of the insertion on the first attempt in an emergency context. Using a micro-guide may facilitate the peripheral venous catheterization in newborns, by guiding the catheter in the vein and, thereby reduce the risk of transfixion of the vascular lumen.

NCT ID: NCT04598061 Recruiting - Spinal Anesthesia Clinical Trials

IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants

RACHI_dex
Start date: October 1, 2020
Phase:
Study type: Observational

- Spinal anesthesia in newborns is one of " Gold standard " techniques in short subumbilical surgeries (less than 30 minutes) with advantage of avoiding the risks inherent to general anesthesia. - Spinal anesthesia of the newborn remains a complex technical procedure with a failure rate of up to 16%. The child's movements and certain degrees of discomfort may also interfere with the successful completion of the procedure. - The second major issue of spinal anesthesia is the limitation of the motor block duration and the need for general anesthesia to complete the surgery - Spinal anesthesia duration can be prolonged by the addition of differents adjuvant such as opioid or alpha 2 adrenergic agonist. - Since 2018, dexmedetomidine, an alpha 2 adrenergic agonist with sedative, analgesic and anxiolytic properties, is being used as a current and standard practice in our anesthesia department. Intravenous administrationis performed ten to twenty minutes before spinal anesthesia placement in all children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour. This strategy ensures the child's comfort and allows the procedure to be performed under optimal conditions for practitionner. - The objective of this study is to review our practices and to evaluate the impact of the use of dexmedetomidine during spinal anesthesia of newborns and infants.

NCT ID: NCT04492579 Completed - Clinical trials for Breast Milk Expression

Newborns Supplemented With Gentle-UHT Donor Milk

Start date: August 3, 2018
Phase: N/A
Study type: Interventional

This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support an exclusive human milk diet and continued breastfeeding through the infant's first week of life. The investigators aim to determine the safety of GHM, and if GHM provided to breastfeeding mothers of outpatient babies with early weight loss will ensure babies adequately gain weight according to age-matched controls.

NCT ID: NCT04410250 Recruiting - Behavior Clinical Trials

Effect of Oral Hygienization in Newborn on Candida Spp Colonization

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

Oral hygiene is one of the most accessible and well-known strategies for the prevention of dental caries. The benefits of this practice after tooth eruption are well established in the literature. Oral hygiene in newborns prior to tooth eruption is controversial, since there is a disagreement between the Dental and Pediatric Associations as to the optimal time to initiate oral hygiene in children and scientific studies in this regard have not yet been performed. Some of these associations recommend starting this practice from the eruption of the child's first tooth. Others recommend beginning the cleansing of the child's oral cavity from birth by cleaning the baby's gingival rollers and tongue. The aim of the present investigation will be to evaluate, through a randomized clinical trial, the influence of oral hygiene in newborns on Candida spp colonization. and on the child's behavior during oral hygiene after tooth eruption. Will be included in the study, pairs of mothers and babies born in the maternity of the Hospital Nossa Senhora da Saúde, in Diamantina, Minas Gerais, Brazil. This will be a rehearsal Randomized clinical trial in which newborns will be allocated into 2 groups, namely: - Newborns whose parents will receive guidelines for oral hygiene before tooth eruption (Group 1); - Newborns whose parents will receive instructions not to perform oral hygiene before tooth eruption (Group 2). The initial data collection will be performed one month after the child's birth and will include oral clinical examinations, saliva collection and questionnaires on the socio-environmental, economic and behavioral aspects of the child and his family. Initial oral clinical examinations will be performed to assess the presence of Candidiasis, and saliva collection will be performed to identify and quantification of Candida spp. These evaluations will be performed again every three months. From the eruption of the first deciduous tooth, the follow-up included an assessment of the baby's behavior during oral hygiene performed by the responsible. This evaluation will be made by the examiner using the Frankl scale and HBCD scale criteria. Statistical analysis will be performed using the Statistical Package for Social Science, version 23.0 and will include descriptive, bivariate and multivariate analyzes.

NCT ID: NCT03637894 Completed - Nutrition Clinical Trials

Immunity Modification of Full Term Infants According to the Type of Feeding and Mode of Delivery

Start date: August 26, 2015
Phase: N/A
Study type: Interventional

This is a single-center, double-blind, randomized controlled trial, with parallel groups and reference group. The aim of the study was to investigate whether feed a fermented formula milk leads to an increase of anti-microbial peptides such as catelecidine, alpha and beta defensins and secretory-IgA, compared to feed a standard formula (Plasmon Primigiorni), according to mode of delivery. Breastfed infants were the reference group.

NCT ID: NCT03142984 Terminated - Newborns Clinical Trials

UK Baby Study Using a Baby Wash and Lotion Regimen

BOND
Start date: July 4, 2017
Phase: N/A
Study type: Interventional

The skin of a newborn has a sensitive skin barrier relative to an older child and an adult. Newborn's skin, for example, is extremely vulnerable to damage by environmental agents such as harsh detergents, some topical oils, and other irritant chemicals. Evolving perspectives on barrier dysfunction in newborn babies has led to the idea that there may be a window of opportunity in the first few months of a newborn's life to change the environmental agents that their skin is exposed to in order to maximize skin health. These environmental changes could involve the use of optimally formulated wash products and emollients, as well as the removal of all other irritant substances that could damage the skin barrier. Further research is required to identify skincare practices that are harmful and those that are positive, and to ultimately ascertain what the optimum skincare routine should be. An important skincare strategy is to identify an appropriate regimen (use of topical emollients and wash products) that will be used to maintain healthy skin in the future. Baby massage in particular has been shown to enhance the bond between mother and newborn, highlighting that early intervention can support skin health while also being a rewarding experience. Gentle Touch/Early Massage: Apply the lotion with a gentle touch to communicate love to your baby and to create a special bonding moment with skin-to-skin touch. Your touch nurtures baby's social, emotional and physical development. Please take your time to apply consciously the lotion on the whole body of your baby while engaging with her/him. Your touch, light but present, will be consistent across all the face and body areas, it is delicate and soft but more than just applying the lotion. Parents/guardians are using products to help care for their newborn's skin and there is a need to help parents/guardians identify the most appropriate products through research. This study aims to help address this need.