Olfactory Stimulation for Very Low Birth Weight Infants

Not Applicable

Completed

• Conditions: Very Low Birth Weight Infant
• Interventions: Behavioral: Olfactory stimulation; Behavioral: Routine nursing care

• Registration Number: NCT05406804
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Study First Submitted: 2022-02-14
• Status Verified: 2022-04
• Study First Submitted QC: 2022-06-02
• Last Update Submitted: 2022-06-02
• Study First Posted: 2022-06-06
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast milk olfactory stimulation care	Olfactory stimulation	Let premature babies smell their mother's breast milk
Routine care	Routine nursing care	Prevent premature babies from smelling their mother's breast milk

Primary Outcome Measures

Name	Time	Method
Ratio of stable heart rate	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.

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China