The Effect of Schumann Resonance on Preterm Newborns
Primary Purpose
Extremely Low Birth Weight
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
extremely low frequency electromagnetic fields
routine care
Sponsored by
About this trial
This is an interventional supportive care trial for Extremely Low Birth Weight
Eligibility Criteria
Inclusion Criteria:
- gestational age (GA) between 32 and 35 weeks
- Neonatal Therapeutic Intervention Scoring System (NTISS) score <9
Exclusion Criteria:
- (1) a diagnosis of congenital anomaly, intrauterine growth retardation, cerebral palsy, or hydrocephalus; (2) an NTISS score>9
Sites / Locations
- Chung Shan Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Extremely low frequency electromagnetic fields
control group
Arm Description
After parental permission for participation was obtained, the preterm newborns were enrolled and divided into the experimental group, which received ELF-EMF therapy after a pretest in addition to regular medical care, and the control group, which received regular medical care only, using a random number table.
routine care
Outcomes
Primary Outcome Measures
Change from Baseline body weight gain at 4 weeks
Although the preterm newborns' body weight was recorded daily, the differences in body weight gain between the two groups were compared every week.The body weights of the preterm newborns were recorded using the same weighing scale at the same time every day.
Secondary Outcome Measures
Change from Baseline sleep quality at 4 weeks
The preterm newborns' sleep quality was recorded daily, the differences in sleep quality between the two groups were compared every week. The preterm' sleep quality was recorded by the sleep tracking devices of Fitbit Alta HR. The correlation coefficient between Alta HR and PSG was 0.85~0.87.
Full Information
NCT ID
NCT05146752
First Posted
November 9, 2021
Last Updated
December 2, 2021
Sponsor
Chung Shan Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05146752
Brief Title
The Effect of Schumann Resonance on Preterm Newborns
Official Title
Application of Schumann Resonance on Premature Infant
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 8, 2019 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
June 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Body weight gain is crucial for preterm newborns, especially those with a low birth weight. Owing to their noninvasive, noncontact, and non-pharmaceutical properties, extremely low frequency electromagnetic fields (ELF-EMFs) are a promising medium of alternative and complementary therapy.
Detailed Description
Sixty-one preterm newborns of 32-35 weeks' gestational age were recruited from the neonatal intensive care unit of the Chung Shan Medical University Hospital and randomly assigned to one of two groups: the experimental group (n = 31) or the control group (n = 30). Both groups received the same medical care, but the experimental group was exposed to ELF-EMFs until discharge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extremely Low Birth Weight
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Extremely low frequency electromagnetic fields
Arm Type
Experimental
Arm Description
After parental permission for participation was obtained, the preterm newborns were enrolled and divided into the experimental group, which received ELF-EMF therapy after a pretest in addition to regular medical care, and the control group, which received regular medical care only, using a random number table.
Arm Title
control group
Arm Type
Other
Arm Description
routine care
Intervention Type
Device
Intervention Name(s)
extremely low frequency electromagnetic fields
Intervention Description
extremely low frequency electromagnetic fields
Intervention Type
Other
Intervention Name(s)
routine care
Intervention Description
routine care
Primary Outcome Measure Information:
Title
Change from Baseline body weight gain at 4 weeks
Description
Although the preterm newborns' body weight was recorded daily, the differences in body weight gain between the two groups were compared every week.The body weights of the preterm newborns were recorded using the same weighing scale at the same time every day.
Time Frame
Baseline, week1, week2, week3, week4.
Secondary Outcome Measure Information:
Title
Change from Baseline sleep quality at 4 weeks
Description
The preterm newborns' sleep quality was recorded daily, the differences in sleep quality between the two groups were compared every week. The preterm' sleep quality was recorded by the sleep tracking devices of Fitbit Alta HR. The correlation coefficient between Alta HR and PSG was 0.85~0.87.
Time Frame
Baseline, week1, week2, week3, week4.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
gestational age (GA) between 32 and 35 weeks
Neonatal Therapeutic Intervention Scoring System (NTISS) score <9
Exclusion Criteria:
(1) a diagnosis of congenital anomaly, intrauterine growth retardation, cerebral palsy, or hydrocephalus; (2) an NTISS score>9
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Schumann Resonance on Preterm Newborns
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