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Clinical Trials/NCT05406804
NCT05406804
Completed
Not Applicable

The Influence of Olfactory Stimulation of Breast Milk on the Stability of Physiological Indicators of Very Low Birth Weight Infants

Children's Hospital of Fudan University1 site in 1 country60 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Very Low Birth Weight Infant
Sponsor
Children's Hospital of Fudan University
Enrollment
60
Locations
1
Primary Endpoint
Ratio of stable heart rate
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This is a RCT study examining whether odor administration to mothers of very low birth weight infants promotes stabilization of vital signs compared with common nursing care. This study used breast milk olfactory stimuli familiar and liked by premature infants to understand the effects of olfactory stimuli on the physiological indicators of very low birth weight infants, the effect on the time of complete enteral nutrition, and the effects on growth and development of very low birth weight infants.

Detailed Description

Fluctuations in vital signs of very low birth weight infants may lead to poor prognosis. Research Objectives: To evaluate the effect of olfactory stimulation of breast milk on the stability of physiological indexes of very low birth weight infants Subjects: Very low birth weight infants whose gestational age are less than 32 weeks.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
October 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Gestational age at birth \<32 weeks;
  • Birth weight \< 1500 g;
  • Admission to hospital within 24 hours after birth;
  • Mother can provide breast milk

Exclusion Criteria

  • Severe congenital malformations;
  • Complicated congenital heart disease;
  • Congenital gastrointestinal disease;
  • Intraventricular hemorrhage

Outcomes

Primary Outcomes

Ratio of stable heart rate

Time Frame: During the procedure.

During the intervention period, the frequency of the measured heart rate between 120 bpm and 160bpm divide the total frequency of heart rate monitoring. The heart rate, blood oxygen saturation and other data will be automatically uploaded to the system by the electrocardiogram monitor every minute, one for each one every minute, which is downloaded by the researcher and then entered into the computer.

Study Sites (1)

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