The Effect of Breast Milk Smell on Nutrition in Preterms

Not Applicable

• Conditions: Digestion; Nutrition; Breast Milk; Preterm Birth; Smell Stimulation
• Interventions: Behavioral: Olfactory stimulation

• Registration Number: NCT04843293
• Lead Sponsor: Selcuk University

Brief Summary

The study was planned to determine the effect of breast milk odor applied during gavage feeding on early feeding cues of preterm newborns, the transition time to oral feeding and abdominal perfusion.

Detailed Description

It is known that nutrient odors stimulate the initiation of digestion. However, in preterm newborns who are fed by gavage or parenterally, exposure to the nutrient smell that initiates digestion disappears. For this reason, it is known that odor stimulation is applied to preterm newborns to improve nutrition. It is known that fragrances such as fragrant essential oils, the smell of breast milk, and amniotic fluid have positive effects such as shortening the transition time to oral feeding in preterm newborns, increasing nutritional tolerance and weight gain, increasing hunger symptoms, providing analgesic effect in painful procedures, and reducing hospital stay. However, no study was found to jointly evaluate the effect of odor stimulation with breast milk on early nutritional cues, transition time to oral nutrition and abdominal perfusion in preterm newborns.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-12-15
• Status Verified: 2021-04
• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-08
• Last Update Submitted: 2021-04-08
• Study First Posted: 2021-04-13
• Last Update Posted: 2021-04-13
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Born at 28-36 weeks of PW
• Birth weight >1000 gr
• 1. and 5. Apgar score average per minute ≥ 6
• Gavage method used in nutrition
• Intermittent infusion method used in nutrition,
• Not receiving mechanical ventilation / CPAP support,
• No medication or treatment is administered by the nasal route,
• Without nasal obstruction,
• Have not received any established medical diagnosis

Read More

Exclusion Criteria

• Drugs that affect gastrointestinal function (drugs that facilitate gastric emptying and gastrointestinal passage of nutrients by increasing gastrointestinal tract motility, and drugs that reduce gastrointestinal tract motility)
• Newborns without breast milk
• Continuous infusion or parenteral feeding method is used in nutrition

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group: Olfactory stimulation group	Olfactory stimulation	Preterm newborns in the initiative group were sniffed the smell of breast milk before and during feeding, except for routine application

Primary Outcome Measures

Name	Time	Method
Early Feeding Tips Tracking Form	Before 1 minute from feeding	The form developed by the researchers in line with the literature includes the physiological and behavioral hunger symptoms of the baby, which are accepted as criteria for starting oral feeding in babies and maintaining oral nutrition successfully and reliably (Kirk, Alder ve King 2007, Ludwig ve Waitzman 2007, White ve Parnell 2013, Holloway 2014, Lubbe 2018). The form consists of 9 items, and the answers to the items are in the form of Yes / No. Evaluation of the items in the form will be done simultaneously and separately by two observers (researcher and clinical nurse) right after the babies begin to feed, and interobserver agreement will be evaluated in order to test the reliability of the form.
Newborn Information Form	First measurement, 5 minutes	It is a form prepared by researchers in accordance with the literature (Yildiz ve ark. 2011, Pillai ve ark. 2018, Schriever ve ark. 2018, Neal-Kluever ve ark. 2019). In the form; gender of the baby, date of birth, method of birth, gestational week at birth, average apgar score (1. and 5. in minutes), birth weight, postnatal age, duration of transition to oral nutrition, daily body weight, nutrition frequency, amount of nutrition, food type, breast milk type, daily vomiting frequency and daily defecation frequency are information.
Abdominal Perfusion and Distension Follow-Up Form	Before 1 minute from feeding	It is a form that contains information about abdominal perfusion level developed by researchers in accordance with the literature (Gay ve ark. 2011, Gillam-Krakauer ve ark. 2013, Thomas ve ark. 2018). Near Infrared Spectroscopy (NIRS) is a noninvasive device used in routine of neonatal intensive care unit and will be used in this study to determine the abdominal perfusion of the baby.

Secondary Outcome Measures

Name	Time	Method
Abdominal Perfusion and Distension Follow-Up Form	The second measurement is 10, 30, 60 and 120 after feeding is completed. minutes.	It is a form that contains information about abdominal perfusion level developed by researchers in accordance with the literature (Gay ve ark. 2011, Gillam-Krakauer ve ark. 2013, Thomas ve ark. 2018). Near Infrared Spectroscopy (NIRS) is a noninvasive device used in routine of neonatal intensive care unit and will be used in this study to determine the abdominal perfusion of the baby.

Trial Locations

Locations (1)

Sibel Kucukoglu; 🇹🇷 Konya, Turkey