The Effect of Schumann Resonance on Preterm Newborns

NCT05146752 | Completed

• 1 other identifier: CS19049
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Extremely Low Birth Weight

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, week1, week2, week3, week4.

Secondary Outcomes (1)

• Change from Baseline sleep quality at 4 weeks

  Baseline, week1, week2, week3, week4.

Study Arms (2)

Extremely low frequency electromagnetic fields

EXPERIMENTAL

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.

Device: extremely low frequency electromagnetic fields

control group

OTHER

routine care

Other: routine care

Interventions

extremely low frequency electromagnetic fields DEVICE

extremely low frequency electromagnetic fields

Extremely low frequency electromagnetic fields

routine care OTHER

routine care

control group

Eligibility Criteria

• Age: 26 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• gestational age (GA) between 32 and 35 weeks
• Neonatal Therapeutic Intervention Scoring System (NTISS) score \<9

You may not qualify if:

• (1) a diagnosis of congenital anomaly, intrauterine growth retardation, cerebral palsy, or hydrocephalus; (2) an NTISS score\>9

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 7, 2021
• Study Start: June 8, 2019
• Primary Completion: February 1, 2021
• Study Completion: June 5, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)