Olfactory Stimulation for Very Low Birth Weight Infants
Primary Purpose
Very Low Birth Weight Infant
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Olfactory stimulation
Routine nursing care
Sponsored by
About this trial
This is an interventional supportive care trial for Very Low Birth Weight Infant focused on measuring Olfactory stimulation, Heart rate, Oxygen saturation, Respiratory rate
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
Sites / Locations
- Children's Hospital of Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Breast milk olfactory stimulation care
Routine care
Arm Description
Let premature babies smell their mother's breast milk
Prevent premature babies from smelling their mother's breast milk
Outcomes
Primary Outcome Measures
Ratio of stable heart rate
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05406804
First Posted
February 14, 2022
Last Updated
June 2, 2022
Sponsor
Children's Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT05406804
Brief Title
Olfactory Stimulation for Very Low Birth Weight Infants
Official Title
The Influence of Olfactory Stimulation of Breast Milk on the Stability of Physiological Indicators of Very Low Birth Weight Infants
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Very Low Birth Weight Infant
Keywords
Olfactory stimulation, Heart rate, Oxygen saturation, Respiratory rate
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breast milk olfactory stimulation care
Arm Type
Experimental
Arm Description
Let premature babies smell their mother's breast milk
Arm Title
Routine care
Arm Type
Active Comparator
Arm Description
Prevent premature babies from smelling their mother's breast milk
Intervention Type
Behavioral
Intervention Name(s)
Olfactory stimulation
Intervention Description
1) For the premature infants who use non-invasive ventilation, place a single layer of gauze soaked in breast milk on the air outlet of the non-invasive ventilator. When inhaling oxygen with a high-flow nasal cannula, the same measure is performed, and the breast milk and sterile gauze soaked in breast milk are replaced every 4 hours. 2) For the premature infants who withdrawn from assisted ventilation, place the breast pad near the infants' nose, and replace the breast milk pad every 4 hours. Acquisition of breast milk pads: use the same brand of breast milk pads; put the breast milk pads used between 00:00 and 07:00 every day (use time > 2 hours) into the same brand of milk storage bags, and use two left and right at the same time. 3) If the premature infants don't have any ventilation support, the breast milk stimulation method is the same as 2). This intervention will continue until premature infants discharge from hospital.
Intervention Type
Behavioral
Intervention Name(s)
Routine nursing care
Intervention Description
Nursing is performed according to existing nursing practices. Nasal feeding is generally used.
Primary Outcome Measure Information:
Title
Ratio of stable heart rate
Description
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.
Time Frame
During the procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Hours
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
12. IPD Sharing Statement
Learn more about this trial
Olfactory Stimulation for Very Low Birth Weight Infants
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