louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04743817: Feasibility Evaluation of OtoSet
Official title: Feasibility Evaluation of the OtoSet - Ear Cleaning System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerumen Impaction of Both Ears
Lead sponsor: SafKan
Sponsor class: INDUSTRY
First posted: 2021-02-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator.

Detailed description: This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator.

Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

Total duration of subject participation will be 1 day with a follow up call within 2-4 days after the procedure. Total duration of the study is expected to be 3 months.

Eligibility criteria: Inclusion Criteria:

* Mild (1), Moderate (2), or Complete (3) occlusion of the ear canal based on the Degree of Occlusion Scale in one or both ears
* Informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion Criteria:

* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data
* Subject has life threatening illness
* Subject has immune deficiency

Primary outcomes:
measure: Efficacy as Assessed by Occlusion Scale
timeFrame: Treatment Visit (Day 1) (pre- to post-procedure)
measure: Safety as Assessed by Adverse Events
timeFrame: Treatment Visit (Day 1) through follow-up call (Day 2-4)
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Eclipse Clinical Research
state: Arizona
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Eclipse Clinical Research
name: Felice Anderson
role: PRINCIPAL_INVESTIGATOR
affiliation: Rainier Clinical Research Center
name: Ronald Brazg, MD, FACE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01300117: Influence of Extracorporeal Circulation During Cardiac Surgery on the Development of Postoperative Thrombotic Thrombocytopenic Purpura (TTP)
Official title: Influence of Extracorporeal Circulation During Cardiac Surgery on the Development of Postoperative TTP
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Surgery
Keywords: cardiac surgery
adamts13
TTP
extracorporeal circulation
Heart-Lung Machine
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2011-02-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery at the University Hospital

Brief summary: The purpose of this study is to determine whether extracorporeal circulation during cardiac surgery has an influence on ADAMTS13-Activity.


Eligibility criteria: Inclusion Criteria:

* cardiac surgery with or without (OPCAB) the use of extracorporeal circulation
* patient agrees

Exclusion Criteria:

* no agreement
* known TTP in medical history

Primary outcomes:
measure: Change in ADAMTS13-Activity over time
timeFrame: during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
Secondary outcomes:
measure: Change in ADAMTS13-Antibody over time
timeFrame: during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
measure: Change in Platelet count over time
timeFrame: during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
measure: time duration of extracorporeal circulation during surgery
timeFrame: during surgery
measure: Amount of intraoperative given fluid replacement
timeFrame: during surgery
measure: Amount of given blood products (red blood cells)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe University Hospital
state: Hessen
Study officials:
References:
Clinical trial NCT00590317: Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department
Official title: Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nausea and Vomiting
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2008-01-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.

Detailed description: Nausea and vomiting can be common symptoms in the emergency department (ED). Antiemetics, agents to treat nausea and vomiting, include phenothiazine derivatives, prokinetic agents, and 5-HT3 antagonists. There have been limited studies on the use of these agents in the ED, and no direct comparisons to 5-HT3 antagonists have been published to date.

Inclusion Criteria:

Patients presenting to the ED with at least one of the following

* nausea
* vomiting documented in the ED

Eligibility criteria: Inclusion Criteria:

* Patients presenting to the ED with at least one of the following
* Nausea
* Vomiting documented in the ED

Exclusion Criteria:

* Previous treatment in the ED with Ondansetron, prochlorperazine, promethazine or metaclopramide
* Patients with missed last menstrual period
* Pregnancy
* Age \< 18 years old
* Treatment with antineoplastic agents within 7 days prior to randomization
* Irritable bowel syndrome
* Gastroparesis
* Suspected gastrointestinal bleed
* Suspected intestinal obstruction
* Preexisting motor disorder (Restless-leg syndrome or Parkinson's disease)
* Traumatic brain injury upon admission to ED
* Intracranial hemorrhage upon admission to ED
* Patients unable to read, write or communicate in the English language
* Patients leaving the ED against medical advice

Primary outcomes:
measure: Vomiting at 0 to 120 Min.
timeFrame: 0 to 120 minutes after receiving medication
Secondary outcomes:
measure: Nausea at 0 to 120 Min
timeFrame: 0 to 120 minutes after receiving medication
measure: Akithisia at 0 to 120 Min
timeFrame: 0 to 120 min after receiving medication
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Hospital
state: Georgia
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Grady Memorial Hospital
name: John Patka, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Daniel T Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00940017: A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects
Official title: A Phase 4, Open Label Study To Assess The Bronchopulmonary Pharmacokinetics Of Anidulafungin And Voriconazole Following Intravenous Administration In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aspergillosis
Candidemia
Keywords: PK
fungal infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung.


Eligibility criteria: Inclusion Criteria:

* Healthy adult subjects willing to comply with the study requirement.

Exclusion Criteria:

* Clinical significant disease.
* Sensitive to study medication.
* Not willing to comply with the study requirement.

Primary outcomes:
measure: Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)
timeFrame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
measure: Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax)
timeFrame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
measure: Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau)
timeFrame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
measure: Plasma PK: Plasma Elimination Half-life (t1/2)
timeFrame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
measure: Plasma PK: Total Clearance (CL Total)
timeFrame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
measure: Plasma PK: Volume of Distribution at Steady-state (Vss)
timeFrame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
measure: Epithelial Lining Fluid (ELF) PK: Cmax
timeFrame: 4, 8, 12, 24 hours after start of infusion
measure: ELF PK: Tmax
timeFrame: 4, 8, 12, 24 hours after start of infusion
measure: ELF PK: AUCtau
timeFrame: 4, 8, 12, 24 hours after start of infusion
measure: ELF PK: t1/2
timeFrame: 4, 8, 12, 24 hours after start of infusion
measure: Alveolar Macrophages (AM): Cmax
timeFrame: 4, 8, 12, 24 hours after start of infusion
measure: AM: Tmax
timeFrame: 4, 8, 12, 24 hours after start of infusion
measure: AM: AUCtau
timeFrame: 4, 8, 12, 24 hours after start of infusion
measure: AM: t1/2
timeFrame: 4, 8, 12, 24 hours after start of infusion
measure: Overall Drug Penetration Ratio in ELF
timeFrame: 4, 8, 12, 24 hours after start of infusion
measure: Concentration Ratio in ELF to Plasma
timeFrame: 4, 8, 12, 24 hours after start of infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00644917: Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment
Official title: Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: wound healing
phototoxicity
Healthy Subjects
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The product is being tested to see if exposure to light causes toxic reactions on the skin.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
measure: Skin Reaction Score
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Healthpoint, Ltd.
name: Innes Cargill, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04166617: Assessment Effectiveness of the Leap Motion Capture® System on the Functionality of the Upper Limb in Acquired Brain Injury
Official title: Assessment Effectiveness of the Leap Motion Capture® System on the Functionality of the Upper Limb in Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Treatment Adherence
Patient Satisfaction
Brain Injuries, Traumatic
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The affectedness of the motor control of the upper limb, particulary, the hand and/or fingers, appears in many neurological diseases, what is going to impact on the functionality of the subject. The use of new technologies in the rehabilitation environment, has the target to reduce the impact on the disabling conditions. So that, the goal of this investigation is to evaluate the system use effectiveness of the Leap Motion Controller® in the treatment on the upper limb on patients with neurological disease.


Eligibility criteria: Inclusion Criteria:

* people aged between 30 and 70 years old;
* with a confirmed diagnosis of brain damage (\>6 months);
* UL motor impairment with a Fugl-Meyer score≥16;
* a modified Ashworth scale score≤2 in the deltoid, triceps brachii, biceps brachii and in the wrist and finger flexor and extensor muscles of the upper limb

Exclusion Criteria:

* the inability to understand instructions and actively cooperate in the tasks indicated based on a score ≥ 24 in the Mini-mental Test;
* refusal to participate in the study;
* visual impairment not correctable by glasses.

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: 8 weeks
measure: Jamar
timeFrame: 8 weeks
measure: Box and blocks
timeFrame: 8 weeks
Secondary outcomes:
measure: Adherence to the therapy sessions
timeFrame: 8 weeks
measure: Questionary of Patient Satifaction
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
References:
Clinical trial NCT00763217: Clinical Biological and Pharmacological Factors Influencing Stroke Outcome
Official title: Characterization of Clinical, Biological and Pharmacological Markers of Stroke Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: inflammation
coagulation
neuroprotection
drugs
clinical neurology
pharmacology
biological factors
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2008-09-30
Enrollment: 550
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort of stroke patient

Brief summary: In a previous suty, we have demonstrated that prior transient ischemic attack, treatment lipid-lowering drug or physical activity are associated to a better outcome of stroke. The aim of the study is to understand the mechanisms of this preventive neuroprotection by establishing link between biomarkers and preventive and neuroprotective measures.To answer to the question, we conduct a cohort study of stroke patients.

Detailed description: In the cohort, the severity of stroke (NIHSS) will be correlated with :

* clinical factors,
* pharmacological factors,
* biological factors (inflammatory markers, hemostasis...)

Eligibility criteria: Inclusion Criteria:

* ischemic or hemorrhage stroke
* hemispheric stroke
* stroke dating from less 48h

Exclusion Criteria:

* non hemispheric stroke
* malformative intracranial hemorrhage
* traumatic intracranial hemorrhage
* subarachnoidal hemorrhage

Primary outcomes:
measure: severity of stroke measured by NIH severity score
timeFrame: inclusion, day7, month3, year3
Secondary outcomes:
measure: clinical, pharmacological and biological (metabolic, inflammation, hemostasis...) cognitive status
timeFrame: inclusion and year3
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille University Hospital - Service de Neurologie vasculaire
Study officials:
affiliation: Lille University Hospital
name: regis BORDET, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colin O, Labreuche J, Deguil J, Mendyk AM, Deken V, Cordonnier C, Deplanque D, Leys D, Bordet R. Preadmission use of benzodiazepines and stroke outcomes: the Biostroke prospective cohort study. BMJ Open. 2019 Jan 15;9(1):e022720. doi: 10.1136/bmjopen-2018-022720.
citation: Moulin S, Leys D, Schraen-Maschke S, Bombois S, Mendyk AM, Muhr-Tailleux A, Cordonnier C, Buee L, Pasquier F, Bordet R. Abeta1-40 and Abeta1-42 Plasmatic Levels In Stroke: Influence of Pre-Existing Cognitive Status and Stroke Characteristics. Curr Alzheimer Res. 2017;14(6):686-694. doi: 10.2174/1567205012666151027141730.
Clinical trial NCT00306917: Clinical Study Comparing Two Implant Surface Finishes in Patients Undergoing Cementless Total Hip Replacement
Official title: A Prospective, Randomized Study of Summit™ Porocoat® Versus Summit™ DuoFix™ HA in Cementless Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis
Avascular Necrosis
Acute Fracture
Keywords: Total Hip Replacement
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2006-03-27
Enrollment: 245
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty

Detailed description: Hydroxyapatite (HA) is a bioactive ceramic that resembles the natural inorganic mineral content of bone, and as such is a highly osteoconductive material. The purpose of this study is to compare an HA coated and uncoated prosthesis.

Eligibility criteria: Inclusion Criteria:

* Primary total hip replacement
* Patient age less than or equal to 75
* Sufficient bone stock to support prosthesis

Exclusion Criteria:

* Previous hip replacement
* Significant angular/bony deformity
* Active joint sepsis
* Metal allergy
* Renal transplant
* Psychosocial disease
* Neurological disease/musculoskeletal disease that may affect weight-bearing

Primary outcomes:
measure: Harris Hip Score (HHS)
timeFrame: Preoperative, 6, 12, 24, 36, 48, and 60 months
Secondary outcomes:
measure: Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure.
timeFrame: Postoperative, 6, 12, 24, 36, 48 and 60 months
Other outcomes:
Locations:
city: Warsaw
country: United States
facility: DePuy Orthopaedics
state: Indiana
Study officials:
affiliation: Orthopaedics Indianapolis
name: David A Fisher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan Orthopaedics Center
name: J W Mesko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Margaret's Hospital Family Orthopaedics
name: Paul Perona, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopaedic Specialists of the Carolinas
name: Stephan B Lowe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pomeroy & Reddy
name: Donald L Pomeroy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pomeroy & Reddy
name: Nithin Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00750217: Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches
Official title: Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches: A Study on Practicability With Patients Maintained With Daily Dosages Between 60mg and 100mg Methadone.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heroin Addiction
Keywords: transfer methadone buprenorphine patch heroin addiction
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2008-09-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Buprenorphine is an important alternative to methadone in the maintenance treatment of heroin addiction. Transfer from methadone to buprenorphine requires a reduction of daily methadone dosage below 30 mg to avoid withdrawal after the first buprenorphine intake. The study hypothesis states that the transfer from a daily methadone dosage between 60 mg and 100 mg to buprenorphine can be carried out without withdrawal using buprenorphine patches (35 micro grams per hour) within 12 to 48 hours after last methadone intake.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 60 years
* Methadone maintenance treatment for at least 3 months preceding the study
* Daily methadone dosage between 60mg amd 100mg
* Sufficient knowledge of German language
* Ability to give informed consent

Exclusion Criteria:

* Daily methadone dosage below 60mg amd over 100mg
* Prescribed use of benzodiazepines over 30 mg equivalent to diazepam
* Misuse or dependence of alcohol and/or GHB/GBL
* Pregnant or breast-feeding women
* Known intolerance of buprenorphine
* Somatic diseases interfering with the study plan

Primary outcomes:
measure: Short Opiate Withdrawal Scale
timeFrame: 14 days
Secondary outcomes:
measure: Heroin use
timeFrame: 60 days
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Psychiatric University Hospital
Study officials:
affiliation: Psychiatric University Hospital
name: Rudolf Stohler, MD
role: STUDY_DIRECTOR
affiliation: Psychiatirc University Hospital
name: Lukas Boesch, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06354517: The Impact of the SENSE Program on NICU
Official title: The Impact of the SENSE Program on Parent and Newborn
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pre-Term
Individualized Developmental Care
Sensory Experiences
Lead sponsor: Yuksek Ihtisas University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 24
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The SENSE program will be applied to babies receiving treatment in the neonatal intensive care unit and the effect of the application on the baby and parents will be examined.

Detailed description: For the growth and health of the baby, the intrauterine environment provides the fetus with protective physical barriers and sensory exposures timed appropriately for its development. These early exposures occur during sensory development in the intrauterine environment, and there are differences in the timing of development of each sense. When the baby is born prematurely, the intrauterine environment is replaced by the Neonatal Intensive Care Unit environment. The sensory environment of the preterm baby includes the experiences of touch, movement, smell, sound, light, frequent nociceptive pain and disruption of sleep. The mismatch between the infant's underdeveloped coping skills and the stimulating NICU environment can cause physiological imbalance, negatively impact growth and development, and ultimately predispose to the development of long-term neurodevelopmental consequences. Although harmful sensory exposures can negatively affect the development of the preterm baby, appropriate positive sensory exposures positively affect brain development.

Eligibility criteria: Inclusion Criteria:

* Being in the first week of life

Exclusion Criteria:

* Congenital anomaly,
* Preterm babies who are not predicted to survive,
* Babies who cannot be followed regularly,
* Parent having a psychiatric problem
* Parents who wish to withdraw from the study

Primary outcomes:
measure: Hammersmıth Neonatal Neurologıcal Examınatıon
timeFrame: 24 hours
measure: Parental Stress Scale: Neonatal Intensive Care Unit
timeFrame: 24 hours
measure: State-trait Anxiety Inventory
timeFrame: 24 hours
measure: Edinburgh Postnatal Depression Scale
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Yuksek Ihtisas University
Study officials:
affiliation: Biruni University
name: Sevim SAVAŞER, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Guven Hospital
name: Ahu ÇIRLAK, PhD
role: PRINCIPAL_INVESTIGATOR
References: