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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Sibel Kucukoglu | Konya |
Lead Sponsor | Collaborator |
---|---|
Selcuk University |
Turkey,
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
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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
N/A | |
Not yet recruiting |
NCT03418311 -
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome
|
N/A | |
Completed |
NCT02993744 -
Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone
|
N/A | |
Active, not recruiting |
NCT02673216 -
Infection and Adverse Pregnancy Outcome
|
||
Completed |
NCT01683565 -
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
|
Phase 4 | |
Completed |
NCT01460576 -
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
|
N/A | |
Completed |
NCT01412931 -
Protein and Ultrasound Indicators of Preterm Birth
|
N/A | |
Completed |
NCT02606058 -
The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?
|
N/A | |
Terminated |
NCT03715530 -
Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
|
N/A | |
Completed |
NCT00422526 -
Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
|
Phase 3 | |
Enrolling by invitation |
NCT04251260 -
Effectiveness of Positioning in Preterm Neonates
|
N/A | |
Completed |
NCT03668860 -
India Dexamethasone and Betamethasone
|
Phase 1 | |
Recruiting |
NCT03638037 -
Correlation Between Maternal Vitamin D Level And Preterm Birth
|
||
Completed |
NCT02225353 -
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
|
Phase 2 | |
Recruiting |
NCT03992534 -
The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth
|
Phase 1 | |
Completed |
NCT03144141 -
Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
|
N/A | |
Completed |
NCT05210985 -
Examination of the Relationship Between Home Affordances With Development
|
||
Completed |
NCT04021654 -
What is the Future of Vulnerable New-borns
|