Olfactory Stimulation for Very Low Birth Weight Infants

Very Low Birth Weight Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05406804
• Other study ID #: NICU olfactory stimulation-01
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: April 2022
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Very Low Birth Weight Infant

Intervention

Behavioral:
• Olfactory stimulation
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.
• Routine nursing care
Nursing is performed according to existing nursing practices. Nasal feeding is generally used.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During the procedure.