Clinical trial NCT04843293: The Effect of Breast Milk Smell on Nutrition in Preterms
Official title: The Effect of Breast Milk Smell on Early Feeding Cues, Transition Period to Oral Nutrition and Abdominal Perfusion in Preterm Newborns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Milk
Digestion
Nutrition
Smell Stimulation
Preterm Birth
Keywords: Breast Milk
Abdominal Perfusion
Preterm Newborn
Smell Stimulation
Feeding
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 56
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Newborn Information Form
timeFrame: First measurement, 5 minutes
measure: Abdominal Perfusion and Distension Follow-Up Form
timeFrame: Before 1 minute from feeding
measure: Early Feeding Tips Tracking Form
timeFrame: Before 1 minute from feeding
Secondary outcomes:
measure: Abdominal Perfusion and Distension Follow-Up Form
timeFrame: The second measurement is 10, 30, 60 and 120 after feeding is completed. minutes.
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Sibel Kucukoglu
Study officials:
affiliation: Selcuk University
name: Sibel Kucukoglu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Selcuk University
name: Adalet Yucel, Master Student
role: STUDY_CHAIR
affiliation: Selcuk University
name: Hanifi Soylu, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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.2013.3. Epub 2013 Feb 7.
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. doi: 10.1038/sj.jp.7211791. Epub 2007 Jul 12.
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. Epub 2018 Dec 19.
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):1433. doi: 10.3390/nu10101433.
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: 10.1097/ANC.0000000000000532.
citation: 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.