Clinical Trials Logo

Neonatal clinical trials

View clinical trials related to Neonatal.

Filter by:
  • Completed  
  • Page 1

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: 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: 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: NCT03272594 Completed - Pain Clinical Trials

The Influence of Breastfeeding on Cortical Activity During Procedures

iCAP
Start date: November 29, 2017
Phase: Phase 3
Study type: Interventional

Background: Even the healthiest infants undergo painful procedures as part of universal medical care. Untreated early pain is associated with heightened pain response during later procedures in infancy and alteration in response to pain in childhood. Oral sucrose is currently considered the standard of care for acute pain relief in infants. Compelling evidence from 57 randomized controlled trials suggests that oral sucrose reduces bio-behavioral pain response. However, recent data examining the influence of oral sucrose on pain-specific brain activity measured using electroencephalogram (EEG) questions the efficacy of this intervention for reducing pain in the infant brain. Evidence supports the effectiveness of breastfeeding as a pain relieving intervention, however, no studies to date have examined the effect of breastfeeding on pain-specific activity in the newborn brain. Aims: The primary aim of this study is to examine the influence of breastfeeding in comparison to oral sucrose on pain-specific activity in the newborn brain during a heel lance. The secondary aim will be to determine if there is convergence among outcome measures in either of the intervention conditions. Methods: Utilizing a single blind, randomized controlled trial design, 126 healthy term infants will be recruited within the first two days of life. Infants will be randomized to have a medically indicated heel lance completed in one of two possible conditions: 1) breastfeeding (n = 63) or 2) sucrose in an infant cot (n = 63). Infants will not be eligible for study participation if they show signs of lower limb tissue damage, have had previous surgery or intraventricular hemorrhage, are born to opioid using mothers or with significant genetic disorders, are unable to breastfeed, or have contraindications to sucrose administration. Pain-specific brain activity will be recorded on EEG for the duration of the blood collection. Infant facial response will be video recorded, and heart rate and oxygen saturation will be measured for calculation of Premature Infant Pain Profile-Revised (PIPP-R) Score, a reliable and valid bio-behavioral measure of pain in infants' 26-44 weeks gestational age. For infants randomized to the breastfeeding condition, data collection will begin with recording of a one-minute baseline (BL1). Following this, a non-painful control stimulus will be applied to the infant's foot to capture a baseline response on EEG to a non-painful event. The infant will then be transferred to the mother and active breastfeeding will be facilitated. A second baseline (BL2) will be recorded prior to heel lance. Pain response will be recorded from the initiation of the heel lance until procedure completion. In the sucrose condition, all monitoring will take place while the infant is in a cot (considered standard of care). Procedures will be consistent with those outlined above with the exception of administration of 24% oral sucrose two minutes prior to the heel lance. Analysis and inference will be calculated based on the intention-to-treat principle. Data from the EEG recording will be grouped into basic waveforms using principal component analysis. Two one-way analysis of variances will be used to assess the effect of stimulation type (non-painful control, painful heel lance) and treatment (24% oral sucrose, breastfeeding) on the principal components. To assess for the effect of treatment on PIPP-R score, group means will be compared using unpaired Student's t-tests. Hypotheses: Infants in the breastfeeding condition will demonstrate both lower pain-specific brain response and lower bio-behavioral pain scores than infants in the sucrose condition. Significance: This will be the first study to examine the effect of breastfeeding on pain-specific brain response in infants. In light of the negative consequences of unmanaged pain in infants, it is imperative that effective pain relieving interventions are utilized. Given recent evidence questioning the analgesic properties of sucrose, findings will have important implications for informing optimal pain management practices in infants.

NCT ID: NCT02379936 Completed - Neonatal Clinical Trials

Evaluation of Lactate Dehydrogenase as Decision Support for Admissions to Neonatal Ward

HildaNeoHan
Start date: August 2013
Phase: N/A
Study type: Interventional

The immediate newborn period is the period of highest morbidity in life. Early signs of serious disease are often vague and difficult to interpret for the non- specialist. Screening lists of clinical signs are useful but have unsatisfactory specificity or sensitivity, cover only one or two diseases, and are complicated to handle in low resource settings. In critically ill newborns, organ failure to one or multiple organ systems is frequently seen due to inadequate circulation to the tissues. Critical disease will cause hypoxia ischemia of the cells in the affected organs followed by energy deficiency. Independently of the condition causing the energy deficiency this will start a series of events, which initially cause a leaking cell membrane leading to that intracellular components, i.e. the enzyme Lactate dehydrogenase (LDH), will leak out into the blood. Previous research in newborns suggests that LDH is a clinically interesting early predictor of serious illness and may thus serve as an important complement to the clinical examination. If the LDH level is elevated the health care personnel will realize that something is wrong and call for appropriate measures. Today LDH analysis is performed at the Dept. of Clinical Chemistry with an inexpensive and accurate method. However, this method needs relatively large blood volumes and the delay between blood sampling and results is rather long, often several hours. In addition LDH is sensitive to hemolysis, which is quite common in blood sampling in newborns. When this is detected at the laboratory a new sample will be needed, thus delaying the result even more. Also, smaller health care facilities rarely have the laboratory equipment needed for the analysis of LDH. The Swedish company Calmark Sweden AB is now launching a point-of-care technology for LDH analysis called "Hilda Neo". LDH is analyzed on an easy-to-use consumable test card together with an "App" on an ordinary smartphone (in the planned study, iPhone 4S). The result is presented within minutes and presence of hemolysis will be simultaneously detected on the device. The investigators speculate that the use of such a LDH test could serve as a diagnostic help for health-care staff in Vietnam in making the decision when to send a potentially sick newborn to a higher level neonatal unit (in this case the NICU at NPH, Hanoi)