The Effect of Breast Milk Smell on Nutrition in Preterms

Sponsor

Selcuk University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04843293

Collaborator

(none)

Enrollment

Location

Arms

9.5

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Milk Digestion Nutrition Smell Stimulation Preterm Birth	Behavioral: Olfactory stimulation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

In this study, stratified sampling was used according to postmenstrual week (PW) and type of nutrition. In order to ensure homogeneity in the intervention and control groups, according to PW [28-(33+6)] and [34-35+6)], according to the type of nutrition [mixed nutrition (breast milk + formula milk)] and [breast milk] 4 layers were formed. Firstly, 56 preterm newborns were divided as random into intervention (group A) and control (group B). Groups A and B were stratified first to the PW, then according to the type of feeding. Permutation was also used to strike a balance between the strata. Block sets were generated for each combination of the prognostic factors (PW and type of nutrition). The intervention and control groups were then randomized into the strata using a random numbers table.In this study, stratified sampling was used according to postmenstrual week (PW) and type of nutrition. In order to ensure homogeneity in the intervention and control groups, according to PW [28-(33+6)] and [34-35+6)], according to the type of nutrition [mixed nutrition (breast milk + formula milk)] and [breast milk] 4 layers were formed. Firstly, 56 preterm newborns were divided as random into intervention (group A) and control (group B). Groups A and B were stratified first to the PW, then according to the type of feeding. Permutation was also used to strike a balance between the strata. Block sets were generated for each combination of the prognostic factors (PW and type of nutrition). The intervention and control groups were then randomized into the strata using a random numbers table.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Breast Milk Smell on Early Feeding Cues, Transition Period to Oral Nutrition and Abdominal Perfusion in Preterm Newborns

Actual Study Start Date :

Dec 15, 2020

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group: Olfactory stimulation group Preterm newborns in the initiative group were sniffed the smell of breast milk before and during feeding, except for routine application	Behavioral: Olfactory stimulation Newborns in the experimental group will be given the smell of breast milk during 3 consecutive feedings and for 3 days in the morning. Smell stimulation will be started 1 minute before gavage feeding and the application of breast milk odor will continue until the feeding ends. A hand-cleaning researcher will drip 15 drops of breast milk on sterile gauze to apply the smell of breast milk. Sterile gauze dripped with breast milk will be placed as close to the newborn's nose as possible and not in contact with the newborn's skin. After the feeding of the newborn is completed, the application of the smell of breast milk will be terminated and the gauze will be removed from the incubator. A new sterile gauze will be used for each feeding, and these processes will be repeated with each smell stimulation for three days.
No Intervention: Control Group Premature newborns in the control group feeds gavage according to the routine of the clinic, and no attempt will be made during feeding.

Arm

Intervention/Treatment

Experimental: Experimental Group: Olfactory stimulation group

Preterm newborns in the initiative group were sniffed the smell of breast milk before and during feeding, except for routine application

Behavioral: Olfactory stimulation

Newborns in the experimental group will be given the smell of breast milk during 3 consecutive feedings and for 3 days in the morning. Smell stimulation will be started 1 minute before gavage feeding and the application of breast milk odor will continue until the feeding ends. A hand-cleaning researcher will drip 15 drops of breast milk on sterile gauze to apply the smell of breast milk. Sterile gauze dripped with breast milk will be placed as close to the newborn's nose as possible and not in contact with the newborn's skin. After the feeding of the newborn is completed, the application of the smell of breast milk will be terminated and the gauze will be removed from the incubator. A new sterile gauze will be used for each feeding, and these processes will be repeated with each smell stimulation for three days.

No Intervention: Control Group

Premature newborns in the control group feeds gavage according to the routine of the clinic, and no attempt will be made during feeding.

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Weeks to 36 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sibel Kucukoglu	Konya		Turkey	42100

Sponsors and Collaborators

Selcuk University

Investigators

Principal Investigator: Sibel Kucukoglu, PhD, Selcuk University
Study Chair: Adalet Yucel, Master Student, Selcuk University
Study Director: Hanifi Soylu, PhD, Selcuk University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Sibel Küçükoğlu, Assoch Prof, Selcuk University

ClinicalTrials.gov Identifier:

NCT04843293

Other Study ID Numbers:

SelcukUAdlt42

First Posted:

Apr 13, 2021

Last Update Posted:

Apr 13, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sibel Küçükoğlu, Assoch Prof, Selcuk University

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Apr 13, 2021