Olfactory Stimulation for Very Low Birth Weight Infants

NCT ID: NCT05406804

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-10-31

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.

Conditions

Very Low Birth Weight Infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Breast milk olfactory stimulation care

Let premature babies smell their mother's breast milk

Group Type: EXPERIMENTAL

Olfactory stimulation

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the breast milk and sterile gauze soaked in breast milk are replaced every 4 hours. 2) For the premature infants who withdrawn from assisted ventilation, place the breast pad near the infants' nose, and replace the breast milk pad every 4 hours.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

Routine care

Prevent premature babies from smelling their mother's breast milk

Group Type: ACTIVE_COMPARATOR

Routine nursing care

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Routine nursing care

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 0 Hours
• Maximum Eligible Age: 24 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40596001 (View on PubMed)

Other Identifiers

NICU olfactory stimulation-01

Identifier Type: -

Identifier Source: org_study_id