The Effect of Breast Milk Smell on Nutrition in Preterms

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04843293
• Other study ID #: SelcukUAdlt42
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2021
• Source: Selcuk University
• Contact: Sibel Kucukoglu, PhD
• Phone: +903322230789
• Email: s_nadaroglu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 36 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Breast Milk
• Digestion
• Nutrition
• Premature Birth
• Preterm Birth
• Smell Stimulation

Intervention

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.

Locations

Country	Name	City	State
Turkey	Sibel Kucukoglu	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Gay AN, Lazar DA, Stoll B, Naik-Mathuria B, Mushin OP, Rodriguez MA, Burrin DG, Olutoye OO. Near-infrared spectroscopy measurement of abdominal tissue oxygenation is a useful indicator of intestinal blood flow and necrotizing enterocolitis in premature pi — View Citation

Gillam-Krakauer M, Cochran CM, Slaughter JC, Polavarapu S, McElroy SJ, Hernanz-Schulman M, Engelhardt B. Correlation of abdominal rSO2 with superior mesenteric artery velocities in preterm infants. J Perinatol. 2013 Aug;33(8):609-12. doi: 10.1038/jp.2013. — View Citation

Kirk AT, Alder SC, King JD. Cue-based oral feeding clinical pathway results in earlier attainment of full oral feeding in premature infants. J Perinatol. 2007 Sep;27(9):572-8. Epub 2007 Jul 12. — View Citation

Neal-Kluever A, Fisher J, Grylack L, Kakiuchi-Kiyota S, Halpern W. Physiology of the Neonatal Gastrointestinal System Relevant to the Disposition of Orally Administered Medications. Drug Metab Dispos. 2019 Mar;47(3):296-313. doi: 10.1124/dmd.118.084418. E — View Citation

Pillai A, Albersheim S, Matheson J, Lalari V, Wei S, Innis SM, Elango R. Evaluation of A Concentrated Preterm Formula as a Liquid Human Milk Fortifier in Preterm Babies at Increased Risk of Feed Intolerance. Nutrients. 2018 Oct 4;10(10). pii: E1433. doi: — View Citation

Thomas S, Nesargi S, Roshan P, Raju R, Mathew S, P S, Rao S. Gastric Residual Volumes Versus Abdominal Girth Measurement in Assessment of Feed Tolerance in Preterm Neonates: A Randomized Controlled Trial. Adv Neonatal Care. 2018 Aug;18(4):E13-E19. doi: 10 — View Citation

Yildiz A, Arikan D, Gözüm S, Tastekin A, Budancamanak I. The effect of the odor of breast milk on the time needed for transition from gavage to total oral feeding in preterm infants. J Nurs Scholarsh. 2011 Sep;43(3):265-73. doi: 10.1111/j.1547-5069.2011.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Newborn Information Form	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.	First measurement, 5 minutes
Primary	Abdominal Perfusion and Distension Follow-Up Form	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.	Before 1 minute from feeding
Primary	Early Feeding Tips Tracking Form	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.	Before 1 minute from feeding
Secondary	Abdominal Perfusion and Distension Follow-Up Form	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.	The second measurement is 10, 30, 60 and 120 after feeding is completed. minutes.

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