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Neonatal clinical trials

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NCT ID: NCT06344741 Recruiting - Pain Clinical Trials

Consequences of Admission to the Delivery Room in the Early and Late Phases

Start date: November 13, 2023
Phase:
Study type: Observational

This study will be conducted to compare maternal and neonatal outcomes of pregnant women who applied to the delivery room in the early (latent) and late (active) phase. The population of the research will consist of participants who applied to Darıca Farabi Training and Research Hospital for birth. To determine the sample size of the study, first, those who meet the inclusion criteria and are admitted to the delivery room in the latent phase and those who are accepted in the active phase will be numbered and recruited sequentially. When the number of participants in the 100 latent and 100 active acceptance groups is reached, the effect size will be calculated using the STAI score averages and the G*Power program, and the exact sample number will be determined, taking into account possible data losses. If necessary, data collection will continue until the target number is reached. Randomization will not be applied in the study. Data will be collected with the maternal and neonatal information form, State and Trait Anxiety Scale (STAI), Fear of Birth Scale, Neonatal Pain and Stress Assessment Scale (ALPS-Neo) and Visual analog scale for birth satisfaction. Data will be collected by the assistant researcher. Statistical analysis will be performed using IBM SPSS Statistic. Descriptive statistical methods will be used to evaluate socio-demographic data, and parametric/nonparametric tests will be used for comparative analyses.

NCT ID: NCT05828420 Completed - Pain Clinical Trials

The Effect of Music, White Noise and Heart Sound on Neonatal Pain

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

Infants are exposed to many painful procedures during their stay in the Neonatal Intensive Care Unit (NICU). Some epidemiological studies report that infants experience an average of 7.5-14 painful procedures per day per infant during the first 14 days of their hospitalization. The most significant problem encountered in understanding pain in infants is the lack of verbal expression of pain. Newborns express their pain with nonverbal behavioral expressions. Therefore, any pain assessment is based on the ability to recognize the pain symptoms of others. The pain experienced may cause physiological imbalances and abnormalities in brain development and stress response in infants in the short and long term. It can negatively affect family-infant communication, as well as cause emotional and psychosomatic problems later in life. Today, music therapy has positive effects on reducing stress, reducing pain, oxygen saturation level, and peak heart rate values in providing individualized developmental care of the infant in neonatal intensive care units. Heart sound, babies hear the mother's heart sound the most during the intrauterine period in the womb. Therefore, when babies hear the sound, they are familiar with in the womb, they will feel safe and a sense of relaxation will occur in the baby. Several studies have proven that playing heartbeat sounds to newborn babies can positively affect their physiological indicators, feeding, length of hospital stay and pain outcomes. The current literature shows that the presence of rhythmic sound can positively affect the neurobehavioral development of the infant and reduce pain. Rhythmic sounds have healing/positive effects on newborns; listening to white noise reduces preterms' pain scores, stabilizes vital signs, and plays an active role in preterms' sleep-wake period. In line with all this information, this study was carried out as a randomized controlled experimental study in order to determine the effects of music played during heel spear application, white noise and heart sound in infants.

NCT ID: NCT05451875 Not yet recruiting - Hypertension Clinical Trials

Comparison of Continuous Non-invasive All Vital Signs Monitoring Devices With Invasive Gold Standard for Children

VT
Start date: January 15, 2023
Phase:
Study type: Observational

In this clinical study, the investigator will compare vital signs measurements obtained using the non-invasive, wireless VitalTracert monitoring devices (both a VT-Watch and a VT-Patch) to a proprietary continuous physiological data collection tool in 40 patients including 16 patients with an invasive arterial line catheter (radial or femoral) at the pediatric intensive care unit.

NCT ID: NCT05223790 Recruiting - Pain Measurement Clinical Trials

Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.

NIPEpréma
Start date: March 22, 2022
Phase:
Study type: Observational

The Newborn Infant Parasympathetic Evaluation (NIPE) was developed as a method of analysis of the heart rate variability. The monitor gives a value between 0 (low value of the parasympathetic component) and 100 (high value of the parasympathetic component). So far, the measure of the heart failure variability by using the NIPE in infant born very premature ventilated and sedated in neonatal reanimation has not been realised and validated as an evaluation method of the pain and discomfort related to neonatal care.

NCT ID: NCT05221463 Completed - Breastfeeding Clinical Trials

The Effect of Video-assisted Breastfeeding Education Given to Mothers of Hospitalized Newborns on Breastfeeding

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

Breastfeeding rates of infants in intensive care units in the world and in Turkey are undesirably low due to the conditions of infants, mothers and healthcare workers, which threatens the health of newborns in many aspects in the early and future periods. It is thought that the visual materials and tools used in breastfeeding education can be effective both in the permanence of the acquired knowledge and in the transformation of the knowledge into behavior. This study was conducted to determine the effect of video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns on breastfeeding self-efficacy and breastfeeding success. Hypotheses Hypothesis 01: Video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns does not affect breastfeeding self-efficacy of mothers. Hypothesis 1: Video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns increases mothers' breastfeeding self-efficacy. Hypothesis 02: Video-assisted breast milk and breastfeeding education given to mothers of hospitalized newborns does not affect mothers' breastfeeding success. Hypothesis 2: Video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns increases the breastfeeding success of mothers. This research is a non-randomized quasi-experimental study in a two-group pretest-posttest design. The research was carried out in the neonatal intensive care level 2 unit of a university hospital located in the north of Turkey. In the study, mothers who met the inclusion criteria were assigned to the education group (EG) (n=44) and the control group (CG) (n=44), some mothers did not continue the education program and left the study. In this case, the study was completed with 41 mothers in EG and 43 mothers in CG. Video assisted breastfeeding training was given to the intervention group. Only the hospital's routine general breastfeeding training was given to the control group, and no other intervention was made.Breastfeeding self-efficacy with the Postpartum Breastfeeding Self-Efficacy Scale-Short Form and breastfeeding success levels with the LATCH Breastfeeding Diagnostic Measurement Tool were evaluated at the beginning of the study (pretest) and after three days of breastfeeding training (posttest).

NCT ID: NCT05036915 Completed - Neonatal Clinical Trials

The Effect of Routine and Random Pacifier Use Methods in Preterm Infants

Start date: May 2, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to determine the effect of the routine 5-min pacifier use before feeding and the random 30-min pacifier use independent from feeding during the day on the transition to bottle feeding process in preterm infants.

NCT ID: NCT04545866 Recruiting - Clinical trials for Respiratory Distress Syndrome

The Budesonide in Babies (BiB) Trial

BiB
Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, masked, active-controlled, multicenter trial designed to determine whether early intratracheal administration of a combination of budesonide with surfactant, as compared to surfactant alone, will reduce the incidence of physiologic bronchopulmonary dysplasia (BPD) or death by 36 weeks' post-menstrual age in extremely preterm infants.

NCT ID: NCT04523441 Completed - Cerebral Palsy Clinical Trials

Early Support and Physiotherapy for Children and Their Motor Skills

App-eMot-Quali
Start date: October 5, 2020
Phase:
Study type: Observational

The App-eMot-Quali project proposed here is the first phase in the implementation of a care pathway supported by a digital tool. It consists of a qualitative study allowing individual interviews to be conducted with parents of infants at high risk of cerebral palsy and health professionals in order to identify and precisely describe the needs and difficulties present during the child's rehabilitative care during the first months of life.

NCT ID: NCT04354467 Completed - Acute Kidney Injury Clinical Trials

Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict AKI in the NICU

Start date: January 28, 2019
Phase:
Study type: Observational

Nephrotoxic medication (NTMx) exposure is one of the most commonly cited causes of acute kidney injury (AKI) in hospitalized children, and is the primary cause of AKI in 16% of cases. Through initial work at UAB/Children's of Alabama Hospital, NTMx exposure was found to be potentially modifiable and the associated AKI is an avoidable adverse safety event. Currently, only serum Creatinine monitoring is available to monitor for NTMx-associated AKI. The hypothesis of this NINJA NGAL study is that urine NGAL is highly sensitive to detect NTMx-associated AKI. UAB/Children's of Alabama is bringing urine NGAL measurement to the infants in the NICU to detect NTMX-associated AKI.

NCT ID: NCT04295564 Active, not recruiting - Premature Birth Clinical Trials

Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function

Start date: January 10, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing.