Premature Clinical Trial
Official title:
Effects of Oriental Music oN Preterm InfAnts: A Randomized Controlled Trial. (OMNIA Trial)
Verified date | February 2022 |
Source | American University of Beirut Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study is to explore the effect of oriental music on premature infants' physiological and behavioral parameters during their hospital stay in the NICU.
Status | Recruiting |
Enrollment | 102 |
Est. completion date | December 30, 2023 |
Est. primary completion date | February 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 28 Days |
Eligibility | Inclusion Criteria: - Clinically stable infants born between 28 and 366/7 weeks of gestation and =31 weeks Post Menstrual Age (PMA). - Infants planned to stay in the NICU for at least 2 weeks at the time of enrollment. Exclusion Criteria: - Congenital anomaly affecting heart rate and hearing, significant brain insult (such as severe or moderate hypoxic ischemic encephalopathy, intraventricular hemorrhage (IVH) grade 3 or 4 or periventricular leukomalacia) that might affect the neurodevelopmental outcome. - Receiving medications that might interfere with heart rate and reaction to music exposure such as midazolam or morphine. |
Country | Name | City | State |
---|---|---|---|
Lebanon | American University of Beirut | Beirut |
Lead Sponsor | Collaborator |
---|---|
American University of Beirut Medical Center |
Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heart rate variability | It consists of changes in the time intervals between consecutive heartbeats called inter-beat intervals (RR). | 3 years | |
Secondary | Mean Respiratory rate | The respiratory rate will be retrieved from bedside monitors. | 3 years | |
Secondary | Oxygen Saturation | The oxygen saturation will be retrieved from bedside monitors. | 3 years | |
Secondary | Behavioral state | The behavioral score will be assessed using a 7- point score by a certified nurse. | 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04067973 -
Impact of Prematurity on the Optic Nerve
|
||
Recruiting |
NCT05968586 -
Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants
|
N/A | |
Not yet recruiting |
NCT05706584 -
The Effect of Metaverse-Based Nursing Skills Laboratory
|
N/A | |
Not yet recruiting |
NCT05530733 -
Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding
|
N/A | |
Withdrawn |
NCT04561700 -
Nutritive Sucking Patterns in Premature Infants
|
N/A | |
Recruiting |
NCT01443273 -
Thrombophilic Risk Factors in Preterm and Infants Treated at Ha'Emek Medical Center Between the Years 1990 to 2010
|
||
Not yet recruiting |
NCT06072625 -
Enteral Feeding of Premature Babies and Olive Oil Supplementation
|
N/A | |
Recruiting |
NCT04866342 -
Servo Controlled Oxygen Targeting (SCO2T) Study: Masimo vs. Nellcor
|
N/A | |
Enrolling by invitation |
NCT04168749 -
Efficacy and Safety of Industrially Prepared 3 Chamber Bag Parenteral Nutrition for Premature Infant
|
||
Recruiting |
NCT04458441 -
Can Warm Skin Disinfection Reduce the Pain Peripheral Central Catheter Application in Premature Babies?
|
N/A | |
Recruiting |
NCT05835817 -
Magnetoencephalography by Optical Pumping Magnetometer
|
N/A | |
Enrolling by invitation |
NCT03061968 -
Study of Applying Acupressure in Low-birth Weight Premature
|
N/A | |
Recruiting |
NCT06207071 -
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
|
N/A | |
Not yet recruiting |
NCT05806684 -
Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
|
||
Recruiting |
NCT05380401 -
Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants
|
N/A | |
Completed |
NCT04298346 -
Neurological Fate, Prematurity and Genetic Susceptibility Factors
|
||
Active, not recruiting |
NCT05343403 -
Parental Participation on the Neonatal Ward - the neoPARTNER Study
|
||
Completed |
NCT04035564 -
Early Sodium Intake in Preterm Newborns
|
Phase 4 | |
Recruiting |
NCT04432636 -
Gut Bacteria and Brain of the Baby
|
N/A | |
Recruiting |
NCT05301309 -
Integrative Early Breastfeeding Support in NICU
|
N/A |