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Premature Baby 26 to 32 Weeks clinical trials

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NCT ID: NCT06348641 Not yet recruiting - Pain Clinical Trials

Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination

Start date: April 20, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn. This was randomised-controlled study in the NICU at the Health Sciences University Bursa High Specialization Training and Research Hospital, Bursa, Turkey. The population of the study will consist of preterms hospitalized in the neonatal intensive care unit during the time period of the study. In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups. Case report form, PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used to collect the study data. Patients included in the study will be examined by the same ophthalmologist. The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher. Infants will be massaged by the researcher in accordance with IAIM guidelines and massage techniques. Total massage time will be equal for each infant. The researcher has an IAIM infant massage certificate. Before starting the infant massage, jewelry will be removed and hands will be washed. In the study, leg and face massage will be applied among the massage techniques in the IAIM guidelines.

NCT ID: NCT06306794 Not yet recruiting - Pain Clinical Trials

Reducing Pain Levels and Increasing Comfort of Premature Infants During Aspiration

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the effect of using amigurumi octopus on the pain and comfort of the newborn in premature infants undergoing endotracheal aspiration. It is a randomized controlled quasi-experimental design. The study will be conducted in the neonatal intensive care unit of Health Sciences University Bursa High Specialization Training and Research Hospital. The population of the study will consist of preterm hospitalized in the neonatal intensive care unit during the period of the conducted study. In the calculation of the sample size, the power level is 80% and the significance level is 5%. It was determined by the statistical expert that the number of babies that should be included for each group is 26 and the total number of babies required for the whole study is 52 when the effect size is determined as 0.8 for the investigation of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable. Based on aforementioned information, the study sample was determined as 80 preterm infants in which 40 for experimental groups and 40 for control groups. Block randomization method will be applied for the randomization of the groups. PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used as a case report form for the collection of the study data. All the patients included in the study will be intervened by the nurse having a neonatal nursing experience by paying attention to aseptic conditions in accordance with the routine aspiration criteria of the unit. Standardization will be ensured by intervening in all patients with the same application by the same nurse. During the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure. Babies will be allowed to touch the octopus for 10 minutes during and after the procedure. Physiologic parameters of the infants before, during and after the procedure will be reported and recorded by camera. According to the video recordings, PIPP-R and PICS scale evaluations of the infants will be made by two research nurses other than the main researcher conducting the study. The routine aspiration application steps of the unit will be applied to the control group without any intervention.

NCT ID: NCT06287710 Recruiting - Clinical trials for Premature Baby 26 to 32 Weeks

Fluid Responsiveness Evaluation by a Non-invasive Method in Children, Extended to PREterm Infants - FRENCH-PREMA

FRENCH-PREMA
Start date: January 17, 2024
Phase:
Study type: Observational

In this study, the investigators aim to validate a non-invasive marker of fluid-responsiveness in preterm infants (term below 37 gestational week) with acute circulatory failure based on standardized abdominal compression. This would allow physicians to identify which patient could benefit from a fluid expansion, thus avoiding a potentially useless or even dangerous fluid expansion, leading to fluid overload. To this end, the investigators will evaluate the diagnostic accuracy (sensitivity and specificity) of stroke volume variation induced by standardized abdominal compression for the diagnosis of fluid responsiveness (based on the gold-standard test: significant increase in cardiac index after fluid expansion).

NCT ID: NCT04251260 Enrolling by invitation - Preterm Birth Clinical Trials

Effectiveness of Positioning in Preterm Neonates

Start date: September 20, 2022
Phase: N/A
Study type: Interventional

Introduction: When babies are born prematurely, they are deprived of their usual space limits (uterus walls). This along with the action of gravity to which they are exposed after birth, makes the neonates have a low muscle tone, acquire a posture of extension, being more irritable and having difficulties with their alertness-sleep cycle. There are few studies that have assessed the effectiveness of positioning of premature neonates. However, none of these studies has focused on exploring the effects of positioning on the patterns of movement and gross motor function of the pre-term neonates. Aim: The aim of this study is to investigate the effects of positioning on the patterns of movement, gross motor development and physiological clinical outcomes of pre-term neonates. Methods: A sample of pre-term neonates of ≤ 32 weeks of gestation from the Neonatal Intensive Care Unit (NICU) of the General University Hospital of Patras will be randomly assigned to two groups. The intervention group will receive positioning with Snuggle up (Philips, USA), while the control group will receive usual care. Outcomes will be assessed with the general movements of Prechtl and the Denver II scale at baseline and at term-age of each neonate. Physiological outcomes will be also assessed such as heart rate, respiratory rate, weight gained from baseline to term-age, days to achieve full oral feeding, days on the ventilator, days on oxygen, and duration of stay in the NICU. Basic characteristics of the neonates will be obtained from their medical record, i.e. weeks of gestation at birth, gender, type of birth (normal or Caesarian), weight at birth, and Αpgar score and will be used to compare the 2 groups for similarities at the baseline of the trial.

NCT ID: NCT03490721 Completed - Clinical trials for Premature Baby 26 to 32 Weeks

Effects of Clustering Care on the Physiological Stability of Preterm Infants.

Start date: September 12, 2018
Phase: N/A
Study type: Interventional

This crossover design experimental study aims to compare the physiological stability of premature newborns during and after a cluster of care compared to a period when they receive standard non clustered care at the neonatal unit.

NCT ID: NCT01424553 Completed - Clinical trials for Bronchopulmonary Dysplasia

Respiratory Outcome at Adolescence of Very Low Birthweight Infants

EPIPAGEADO
Start date: October 2011
Phase: N/A
Study type: Interventional

EPIPAGEADO is an observational study. Respiratory symptoms and lung function will be evaluated in very low birth weight and term infants, born in 1997 and included in the French EPIPAGE cohort.