The Effect of Breast Milk Smell on Nutrition in Preterms

NCT04843293 | Unknown

• 1 other identifier: SelcukUAdlt42
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Milk; Digestion; Nutrition; Smell Stimulation; Preterm Birth

Keywords

Breast Milk; Abdominal Perfusion; Preterm Newborn; Smell Stimulation; Feeding

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Abdominal Perfusion and Distension Follow-Up Form

  The second measurement is 10, 30, 60 and 120 after feeding is completed. minutes.

Study Arms (2)

Experimental Group: Olfactory stimulation group

EXPERIMENTAL

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

Behavioral: Olfactory stimulation

Control Group

NO INTERVENTION

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

Interventions

Olfactory stimulation BEHAVIORAL

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.

Experimental Group: Olfactory stimulation group

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Born at 28-36 weeks of PW
• Birth weight \>1000 gr
• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Sibel Kucukoglu

Konya, 42100, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• 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 piglets. J Pediatr Surg. 2011 Jun;46(6):1034-40. doi: 10.1016/j.jpedsurg.2011.03.025.

  PMID: 21683194 RESULT

• 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.2013.3. Epub 2013 Feb 7.

  PMID: 23392317 RESULT

• 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. doi: 10.1038/sj.jp.7211791. Epub 2007 Jul 12.

  PMID: 17625573 RESULT

• 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. Epub 2018 Dec 19.

  PMID: 30567878 RESULT

• 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):1433. doi: 10.3390/nu10101433.

  PMID: 30287775 RESULT

• 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: 10.1097/ANC.0000000000000532.

  PMID: 30015674 RESULT

• Yildiz A, Arikan D, Gozum 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.1547-5069.2011.01410.x. Epub 2011 Jul 25.

  PMID: 21884372 RESULT

• Yucel A, Kucukoglu S, Soylu H. The Effect of Breast Milk Odor on Feeding Cues, Transition Time to Oral Feeding, and Abdominal Perfusion in Premature Newborns: A Randomised Controlled Trial. Biol Res Nurs. 2024 Jan;26(1):160-175. doi: 10.1177/10998004231200784. Epub 2023 Sep 8.

  PMID: 37682253 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sibel Kucukoglu, PhD

  Selcuk University

  PRINCIPAL INVESTIGATOR

• Adalet Yucel, Master Student

  Selcuk University

  STUDY CHAIR

• Hanifi Soylu, PhD

  Selcuk University

  STUDY DIRECTOR

Central Study Contacts

Sibel Kucukoglu, PhD

CONTACT

+903322230789; s_nadaroglu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoch Prof

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: December 15, 2020
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)