Olfactory Stimulation for Very Low Birth Weight Infants

NCT05406804 | Completed

• 1 other identifier: NICU olfactory stimulation-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Very Low Birth Weight Infant

Keywords

Olfactory stimulation; Heart rate; Oxygen saturation; Respiratory rate

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Breast milk olfactory stimulation care

EXPERIMENTAL

Let premature babies smell their mother's breast milk

Behavioral: Olfactory stimulation

Routine care

ACTIVE COMPARATOR

Prevent premature babies from smelling their mother's breast milk

Behavioral: Routine nursing care

Interventions

Olfactory stimulation BEHAVIORAL

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the breast milk and sterile gauze soaked in breast milk are replaced every 4 hours. 2) For the premature infants who withdrawn from assisted ventilation, place the breast pad near the infants' nose, and replace the breast milk pad every 4 hours.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.

Breast milk olfactory stimulation care

Routine nursing care BEHAVIORAL

Nursing is performed according to existing nursing practices. Nasal feeding is generally used.

Routine care

Eligibility Criteria

• Age: 0 Hours - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (1)

• Yu L, Tao Y, Jia P, Li L, Lv T, Wang L, Song Q, Huan X, Liu C, Dou Y, Xuan Y, Hu XJ. Effect of breast milk olfactory experience on physiological indicators in very low birth weight infants: a randomized clinical trial. Sci Rep. 2025 Jul 1;15(1):20590. doi: 10.1038/s41598-025-05809-0.

  PMID: 40596001 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: June 6, 2022
• Study Start: July 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: June 6, 2022

Record last verified: 2022-04

Locations

CN (1)