clinlcal trial, effect of breast milk odor and formula milk odor and distilled water on physiologic parameter and weight changes in premature infants

Effect of breast milk odor on physiologic parameter and weight in premature neonate

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014070818397N1

Enrollment

180

Registered

2014-09-03

Start date

2014-03-20

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PHYSIOLOGIC PARAMETER AND WEIGHT. Factors influencing health status and contact with health services

Interventions

Intervention 1: 1-Intervention group1: breast milk odor, 1.5 cc of breast milk odor pour on a 4*4 gauze put in 3 centimeters far from infants nostril. Intervention 2: 2-Intervention group2: formula od

Prevention

Placebo

1-Intervention group1: breast milk odor, 1.5 cc of breast milk odor pour on a 4*4 gauze put in 3 centimeters far from infants nostril.

2-Intervention group2: formula odor, 1.5 cc of just diluted formula milk from Bebelac company pour on a 4*4 gauze put in 3 centimeters far from infants nostril.

3-Intervention group3: distilled water, 1.5 cc of distilled water pour on a 4*4 gauze put in 3 centimeters far from infants nostril.

4- control group: no intervention will be done and just expose to environmental odor.

Eligibility

Sex/Gender

All

Age

No minimum to 7 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: 24 hours after birth; gestational age 30 until 34 at birth; caring in incubator; Stable physiologic parameter; body temperature 36.2 until 37.2; Apgar higher than 7 at minute 5 after birth; spontaneous respiration infant does not need ventilator; the mother does not smoke cigarette or use drugs and alcohol; no sign of major congenital abnormality and infection. Exclusion criteria: the parents don’t like to continue participation in research; secondary infection; convulsion; recurrent apnea; need to ventilator or cpap; Intraventricular hemorrhage grade 3 or 4 based on brain sonography on third day ; discharge and expire before completion of intervention.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Weight. Timepoint: daily for 1 week. Method of measurement: gram.;Heart rate. Timepoint: before and after stimulation, twice a day for 1 week. Method of measurement: beat/ min.	—

Secondary

Measure	Time frame
Respiratory rate. Timepoint: during stimulation, twice a day for 1 week. Method of measurement: beat/min.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNarjes Dehghanian

Mashhad University of Medical Sience

nms.it@mums.ac.ir; dehghaniann901@ mums.ac.ir+98 51 1859 1511

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026