Breast MilkNCT04843293
The Effect of Breast Milk Smell on Nutrition in Preterms
A study testing Olfactory stimulation in people with Breast Milk and Digestion, run by Selcuk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 28 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Breast Milk, Digestion, Nutrition
- What is being tested?
- Olfactory stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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,
Show all 9Show fewer
- No medication or treatment is administered by the nasal route,
- Without nasal obstruction,
- Have not received any established medical diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sibel Kucukoglu
Konya, 42100
Sibel Kucukoglu, PhD, +903322410041, s_nadaroglu@hotmail.com
About this study
Official title: The Effect of Breast Milk Smell on Early Feeding Cues, Transition Period to Oral Nutrition and Abdominal Perfusion in Preterm Newborns
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.
Read the 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.
- Conditions
- Breast Milk, Digestion, Nutrition, Smell Stimulation, Preterm Birth
- Being tested
- Olfactory stimulation
- Keywords
- Breast Milk, Abdominal Perfusion, Preterm Newborn, Smell Stimulation, Feeding
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory stimulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Before 1 minute from feeding
Secondary outcomes (1)
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.
Measured: The second measurement is 10, 30, 60 and 120 after feeding is completed. minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start15 Dec 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Breast MilkStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Küçükoğlu, Selcuk University
- Investigators
- Sibel Kucukoglu, PhD, Principal investigator, Selcuk UniversityAdalet Yucel, Master Student, Study chair, Selcuk UniversityHanifi Soylu, PhD, Study director, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843293
- Sponsor's protocol ID
- SelcukUAdlt42
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published.
Publications
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.
PubMed 21683194Gillam-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.
PubMed 23392317Kirk 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.
PubMed 17625573Neal-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.
PubMed 30567878Pillai 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.
PubMed 30287775Thomas 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.
PubMed 30015674Yildiz 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.
PubMed 21884372Yucel 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.
PubMed 37682253
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breast Milk Smell on Early Feeding Cues, Transition Period to Oral Nutrition and Abdominal Perfusion in Preterm Newborns
- ClinicalTrials.gov ID
- NCT04843293
- Acronym / sponsor ID
- SelcukUAdlt42
- Conditions
- Breast Milk, Digestion, Nutrition, Smell Stimulation, Preterm Birth
- Keywords
- Breast Milk, Abdominal Perfusion, Preterm Newborn, Smell Stimulation, Feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Olfactory stimulation group | Experimental | Behavioral: Olfactory stimulationPreterm newborns in the initiative group were sniffed the smell of breast milk before and during feeding, except for routine application |
| 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. |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olfactory stimulationNewborns 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. | Behavioural | Experimental Group: Olfactory stimulation group |
Primary outcome
Newborn Information Form
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Abdominal Perfusion and Distension Follow-Up Form
Time frame: The second measurement is 10, 30, 60 and 120 after feeding is completed. minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Results publication: PubMed 21683194Gay 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 publication: PubMed 23392317Gillam-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 publication: PubMed 17625573Kirk 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 publication: PubMed 30567878Neal-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 publication: PubMed 30287775Pillai 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 publication: PubMed 30015674Thomas 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 publication: PubMed 21884372Yildiz 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.
- Derived from this study: PubMed 37682253Yucel 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.
- Individual participant dataSharing planned: No. It will be shared after the article is published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibel Kucukoglu, PhD principal investigator
Selcuk University
Adalet Yucel, Master Student study chair
Selcuk University
Hanifi Soylu, PhD study director
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olfactory stimulation in people with Breast Milk and Digestion, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sibel Kucukoglu, PhD (+903322230789 ext. 30789, s_nadaroglu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newborn Information Form (time frame: First measurement, 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04843293, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.