The Effect of Schumann Resonance on Preterm Newborns

Not Applicable

Completed

• Conditions: Extremely Low Birth Weight
• Interventions: Device: extremely low frequency electromagnetic fields; Other: routine care

• Registration Number: NCT05146752
• Lead Sponsor: Chung Shan Medical University

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.

Study Timeline

• Study Start: 2019-06-08
• Primary Completion: 2021-02-01
• Study Completion: 2021-06-05
• Study First Submitted: 2021-11-09
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-02
• Last Update Submitted: 2021-12-02
• Study First Posted: 2021-12-07
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extremely low frequency electromagnetic fields	extremely low frequency electromagnetic fields	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.
control group	routine care	routine care

Primary Outcome Measures

Name	Time	Method
Change from Baseline body weight gain at 4 weeks	Baseline, week1, week2, week3, week4.	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

Name	Time	Method
Change from Baseline sleep quality at 4 weeks	Baseline, week1, week2, week3, week4.	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.

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, Taiwan