Back to resultsThe Effect of Breast Milk Smell on Nutrition in Preterms
Primary Purpose
Breast Milk, Digestion, Nutrition
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Olfactory stimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Milk focused on measuring Breast Milk, Abdominal Perfusion, Preterm Newborn, Smell Stimulation, Feeding
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
Sites / Locations
- Sibel KucukogluRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group: Olfactory stimulation group
Control Group
Arm Description
Preterm newborns in the initiative group were sniffed the smell of breast milk before and during feeding, except for routine application
Premature newborns in the control group feeds gavage according to the routine of the clinic, and no attempt will be made during feeding.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04843293
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Milk, Digestion, Nutrition, Smell Stimulation, Preterm Birth
Keywords
Breast Milk, Abdominal Perfusion, Preterm Newborn, Smell Stimulation, Feeding
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group: Olfactory stimulation group
Arm Type
Experimental
Arm Description
Preterm newborns in the initiative group were sniffed the smell of breast milk before and during feeding, except for routine application
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Premature newborns in the control group feeds gavage according to the routine of the clinic, and no attempt will be made during feeding.
Intervention Type
Behavioral
Intervention Name(s)
Olfactory stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Newborn Information Form
Description
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.
Time Frame
First measurement, 5 minutes
Title
Abdominal Perfusion and Distension Follow-Up Form
Description
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.
Time Frame
Before 1 minute from feeding
Title
Early Feeding Tips Tracking Form
Description
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.
Time Frame
Before 1 minute from feeding
Secondary Outcome Measure Information:
Title
Abdominal Perfusion and Distension Follow-Up Form
Description
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.
Time Frame
The second measurement is 10, 30, 60 and 120 after feeding is completed. minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sibel Kucukoglu, PhD
Phone
+903322230789
Ext
30789
Email
s_nadaroglu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibel Kucukoglu, PhD
Organizational Affiliation
Selcuk University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adalet Yucel, Master Student
Organizational Affiliation
Selcuk University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hanifi Soylu, PhD
Organizational Affiliation
Selcuk University
Official's Role
Study Director
Facility Information:
Facility Name
Sibel Kucukoglu
City
Konya
ZIP/Postal Code
42100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sibel Kucukoglu, PhD
Phone
+903322410041
Email
s_nadaroglu@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
It will be shared after the article is published.
Citations:
PubMed Identifier
21683194
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.
Results Reference
result
PubMed Identifier
23392317
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.
Results Reference
result
PubMed Identifier
17625573
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.
Results Reference
result
PubMed Identifier
30567878
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.
Results Reference
result
PubMed Identifier
30287775
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.
Results Reference
result
PubMed Identifier
30015674
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.
Results Reference
result
PubMed Identifier
21884372
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.
Results Reference
result
Learn more about this trial
The Effect of Breast Milk Smell on Nutrition in Preterms
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