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Olfactory Stimulation for Very Low Birth Weight Infants

Fudan University logo

Fudan University

Status

Completed

Conditions

Very Low Birth Weight Infant

Treatments

Behavioral: Routine nursing care
Behavioral: Olfactory stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05406804
NICU olfactory stimulation-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

Under 24 hours old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Breast milk olfactory stimulation care
Experimental group
Description:
Let premature babies smell their mother's breast milk
Treatment:
Behavioral: Olfactory stimulation
Routine care
Active Comparator group
Description:
Prevent premature babies from smelling their mother's breast milk
Treatment:
Behavioral: Routine nursing care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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