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Newborn clinical trials

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NCT ID: NCT05064683 Completed - Newborn Clinical Trials

The Effect of Facilitated Tucking and White Noise on Stress and Sleep of Newborns in Nasal CPAP

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

Purpose: Newborns go through biochemical and physiological changes involving all their systems in the first days of their lives and may experience difficulties in adapting to extrauterine life due to various reasons. For newborns whose systems are still immature, leaving the warm, dark, quiet, calm, fluid-filled mother's womb and placing them in the intensive care unit with many stimuli creates intense stress and negatively affects the sleep-wake order necessary for brain development and maturation. Newborns have extensive sleep requirements for the development of their neurosensory system. It is known that the brain activity of newborns in the intrauterine period is similar to the REM (Rapid Eye Movement) sleep activity, and they sleep more than adults and spend most of their sleep in the REM sleep period.Therefore, sleep quality in the newborn period is directly related to healthy development.In this direction, our research was carried out to examine the effects of fetal position and white noise on stress and sleep in newborns with nasal CPAP(Continuous Positive Airway Pressure). Design and Methods: . This randomized experimental study was conducted on 108 newborns at the gestational week of 26 or higher in the newborn intensive care unit of a university hospital. The researcher applied white noise (n:36), and facilitated tucking(n:36) to the newborns. The control group (n: 36) received no intervention except for the routine clinical practices. Facilitated tucking white noise interventions were applied to the newborns included in study for 24 hours, their stress levels were monitored with the neonatal stress scale, and their sleep durations were monitored with a sleep-wakefulness measurement device and recorded in the newborn follow-up form. Statistical analysis was performed using percentages, means, and ANOVA test.

NCT ID: NCT04869176 Completed - Clinical trials for Heart Rate Variability

Effect of Caffeine on Heart Rate Variability in Newborns

Start date: November 17, 2017
Phase: N/A
Study type: Interventional

The aim of this study was to evaluate the impact of caffeine treatment, given either orally or intravenously, on heart rate variability in newborns. In addition, the investigators sought for a potential association between caffeine treatment and vital functions.

NCT ID: NCT04827849 Completed - Nursing Caries Clinical Trials

Theory of Meleis on Women's Adaptation to Motherhood and Perceptions of Newborn Baby

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

A randomised control trial will made to determine the effects of nursing care based on Meleis's Theory of Transition on Adaptation of Women to Motherhood and their Perception of New-born Infant

NCT ID: NCT04625010 Completed - Pain Clinical Trials

The Effectiveness of Two Different Methods Applied During Heel Blood Collection on Pain Level of Healthy Term Newborns

Start date: March 1, 2016
Phase: N/A
Study type: Interventional

This study was planned to evaluate the effect of two different non-pharmacologic pain relief methods (swaddling and maternal holding) on healthy term newborn's pain levels during heel stick. Study hypotheses are; Hypothesis 1. Swaddling is effective at relieving pain due to heel stick procedures in newborns. Hypothesis 2. Maternal holding is effective at relieving pain due to heel stick in newborns. Hypothesis 3. Maternal holding is more effective than swaddling at relieving pain due to heel stick in newborns.

NCT ID: NCT04470596 Completed - Newborn Clinical Trials

Clinical Evaluation of Early Onset Neonatal Infection

CLEEONI
Start date: August 9, 2020
Phase:
Study type: Observational

Early bacterial neonatal infection (INBP) defined as occurring in the first 3 days and by extension in the first week of life, remains to this day the leading cause of neonatal morbidity and mortality in developed countries. The germs most frequently found are Streptococcus B (SB) for term newborns (> 37 Weeks of Amenorrhea SA) and Escherichia coli (E. coli) in premature newborns. Although in France, its incidence of 0.4 / 1000 is lower than in other developed countries (0.8 / 1000 general incidence), it remains a major public health concern. The infection criteria were defined by the National Agency for Health Accreditation and Assessment (ANAES) in 2002, allowing to differentiate between proven infections and highly probable cases of infection. Infection is considered to be proven when SB or E. coli is detected in blood culture or in cerebrospinal fluid. An infection is considered to be highly probable in the event of association of clinical signs (fever, polypnea, desaturation, tachycardia, etc.) evoking a beginning sepsis associating with a disturbance of the biological balance sheet (elevation of CRP, hyperleukocytosis, evidence of colonization on peripheral samples). These criteria remain valid to this day to define the infection. In order to define the newborns to be monitored, risk factors were established after a review of the literature in 2002. They make it possible to decide on diagnostic management and / or the setting up of a treatment. Since the recommendations of the ANAES of 2002, the rule, from the presence of a major criterion, was to carry out bacteriological samples peripheral to the birth (gastric liquid, swab of ear and anus) and to systematically collect a CRP of the child between H12 and H48. In the presence of an isolated minor risk factor, simple clinical monitoring (routine) was recommended for 48 hours without deciding firmly on the need for a biological sample. However, it is important to note that these two categories of signs are defined and classified in descending order of risk. This classification does not prejudge a systematic therapeutic attitude. In many situations, the choice is actually left to the practitioner depending on the context. In 2017, new recommendations were implemented by the French Society of Pediatrics (SFP) and the French Society of Neonatology (SFN) regarding the prevention of INBP. These take up the risk factors of the 2002 ANAES by adding PCR SB at the same level as the traditional PV. They define 3 categories of children according to the risk of INBP and the associated care. In most cases, these new practices make it possible to dispense with costly blood and bacteriological samples, which cause discomfort and pain for children. In addition, the use of gastric fluid is not internationally validated, its use in the management case remains very controversial. In case of delayed CRP or positive peripheral samples to the germs generated, and even in the absence of clinical signs, antibiotic therapy was almost systematically initiated. Unnecessary exposure to antibiotics promotes the development of bacteriological resistance and unbalances the neonatal flora. Following the implementation of these new recommendations at the Notre Dame de Bon Secours maternity hospital, which is the case in few centers today and no national survey has yet been carried out on their application, it therefore seems necessary to us evaluate the application of these new recommendations and verify that they allow the detection of all probable or proven infections.

NCT ID: NCT04422041 Completed - Newborn Clinical Trials

Comparison of Early Versus Very Early Postnatal Discharge on Hospital Readmissions in Newborns

Start date: July 1, 2016
Phase: N/A
Study type: Interventional

This study compared hospital readmission and complications between very early discharge and early discharge in healthy newborn patients.

NCT ID: NCT04386798 Completed - Anxiety Clinical Trials

Stress and Anxiety Levels of Mothers Lying in the Baby Newborn Intensive Care Unit

Start date: July 25, 2020
Phase: N/A
Study type: Interventional

Although coronaviruses (CoV) cause mild infections in the community, such as colds, they can also cause more severe infections. There are many subspecies of coronaviruses that can pass from animals to humans and can be transmitted between humans. One of these subspecies is COVID-19 (severe acute respiratory syndrome coronavirus 2), SARS-CoV-2, and has made a worldwide pandemic from the beginning of 2020. In this process, going out of the house, going to the hospital and being in the hospital brings with it the anxiety to get sick. In the period when the feeling of motherhood begins at the end of birth, the hospitalization of the baby for any reason and the separation of the mother and the baby can be an additional source of stress. This study was planned to determine the anxiety and anxiety levels of mothers who had a baby in the NICU during Coronavirus disease pandemic and the factors affecting them.

NCT ID: NCT04293601 Completed - Newborn Clinical Trials

Pressure Injuries' Prevention in Newborn Infants Admitted to NICU

Start date: December 2, 2019
Phase: N/A
Study type: Interventional

Nasal Continuous Positive Airway Pressure (NCPAP) is a respiratory support for neonates with Respiratory Distress Syndrome (RDS) and represents the gold standard for RDS treatment in many Neonatal Intensive Care Units (NICU). Respiratory supports providing Synchronized Nasal Intermittent Positive Pressure Ventilation may further enhance the success of non-invasive respiratory support. The most significant risk factor associated to NCPAP management is nasal trauma. Nasal injuries represent a source of pain and discomfort for infants. In some cases, they could become a site of infection and cause functional, cosmetic, long term outcomes as erythema or necrosis of the columella nasi. The aim of this study is to evaluate the effectiveness of nursing interventions to reduce the incidence of pressure injuries during NCPAP support in infants admitted to NICU. It is hypothesized that implementation of some preventive interventions could improve nursing care quality and reduce nasal pressure injuries.

NCT ID: NCT04218929 Completed - Newborn Clinical Trials

Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

Start date: December 10, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).

NCT ID: NCT03969459 Completed - Microbiota Clinical Trials

Impact of Exposure to Persistent Organic Pollutants During Pregnancy on the Composition of Breast Milk and Consequences on the Newborn

PESTIMICOBLAIT
Start date: May 28, 2019
Phase:
Study type: Observational

Epidemiological studies link early exposure to persistent organic pollutants (POPs) with health consequences in the newborn. Experimental studies have shown the impact of POPs on the gut microbiota. This project aims to characterize the POPs content in breast milk in an exposed population and to evaluate the impact on breast milk composition and intestinal microbiota establishment in the newborn. The health consequences will be evaluated by the clinical follow-up of the newborn.