Premature Birth Clinical Trial
— SOFTOfficial title:
Effects on Coordination of Sucking, Swallowing and Breathing Process of a Valved Feeding System in Late-preterm Newborns. The Safe Oral Feeding Trial (SOFT)
Verified date | August 2023 |
Source | University of Turin, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparing with a randomized controlled trial two different feeding systems in two groups of late-preterm newborns for evaluating which is more efficient in promoting the coordination in the process of sucking-swallowing-breathing and better cardiorespiratory stability. The B-ESP group will be fed with a feeding system with a valved ergonomic teat; the B-STD with a standard feeding system.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 31, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 5 Days |
Eligibility | Inclusion Criteria: - Gestational age 34+0 - 36+6 weeks at birth; - Exclusive oral feeding; - Bottle-feeding for at least a meal a day; Exclusion Criteria: - Newborns with exclusive breastfeeding; - Newborns with congenital anomalies, perinatal asphyxia, respiratory or neurological issues, genetic syndromes, infections, metabolic diseases; - Ongoing administration of medication able to interfere with esophageal or respiratory function; - Newborns who require respiratory support, including oxygen-therapy via nasal-cannula; - Newborns who require oral or nasal feeding tube; |
Country | Name | City | State |
---|---|---|---|
Italy | Città della Salute e della Scienza - Ospedale S.Anna - University of Turin | Turin |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy |
Italy,
Cannon AM, Sakalidis VS, Lai CT, Perrella SL, Geddes DT. Vacuum characteristics of the sucking cycle and relationships with milk removal from the breast in term infants. Early Hum Dev. 2016 May;96:1-6. doi: 10.1016/j.earlhumdev.2016.02.003. Epub 2016 Mar 8. — View Citation
Chen CH, Wang TM, Chang HM, Chi CS. The effect of breast- and bottle-feeding on oxygen saturation and body temperature in preterm infants. J Hum Lact. 2000 Feb;16(1):21-7. doi: 10.1177/089033440001600105. — View Citation
da Costa SP, van der Schans CP, Zweens MJ, Boelema SR, van der Meij E, Boerman MA, Bos AF. The development of sucking patterns in preterm, small-for-gestational age infants. J Pediatr. 2010 Oct;157(4):603-9, 609.e1-3. doi: 10.1016/j.jpeds.2010.04.037. Epub 2010 Jun 14. — View Citation
Dalgleish SR, Kostecky LL, Blachly N. Eating in "SINC": Safe Individualized Nipple-Feeding Competence, a Quality Improvement Project to Explore Infant-Driven Oral Feeding for Very Premature Infants Requiring Noninvasive Respiratory Support. Neonatal Netw. 2016;35(4):217-27. doi: 10.1891/0730-0832.35.4.217. — View Citation
Fucile S, McFarland DH, Gisel EG, Lau C. Oral and nonoral sensorimotor interventions facilitate suck-swallow-respiration functions and their coordination in preterm infants. Early Hum Dev. 2012 Jun;88(6):345-50. doi: 10.1016/j.earlhumdev.2011.09.007. Epub 2011 Sep 29. — View Citation
Geddes DT, Sakalidis VS, Hepworth AR, McClellan HL, Kent JC, Lai CT, Hartmann PE. Tongue movement and intra-oral vacuum of term infants during breastfeeding and feeding from an experimental teat that released milk under vacuum only. Early Hum Dev. 2012 Jun;88(6):443-9. doi: 10.1016/j.earlhumdev.2011.10.012. Epub 2011 Nov 26. — View Citation
Goldfield EC, Richardson MJ, Lee KG, Margetts S. Coordination of sucking, swallowing, and breathing and oxygen saturation during early infant breast-feeding and bottle-feeding. Pediatr Res. 2006 Oct;60(4):450-5. doi: 10.1203/01.pdr.0000238378.24238.9d. Epub 2006 Aug 28. — View Citation
Gross RD, Trapani-Hanasewych M. Breathing and Swallowing: The Next Frontier. Semin Speech Lang. 2017 Apr;38(2):87-95. doi: 10.1055/s-0037-1599106. Epub 2017 Mar 21. — View Citation
Joshi R, van Pul C, Sanders A, Weda H, Bikker JW, Feijs L, Andriessen P. A Strategy to Reduce Critical Cardiorespiratory Alarms due to Intermittent Enteral Feeding of Preterm Neonates in Intensive Care. Interact J Med Res. 2017 Oct 20;6(2):e20. doi: 10.2196/ijmr.7756. — View Citation
Lau C, Smith EO, Schanler RJ. Coordination of suck-swallow and swallow respiration in preterm infants. Acta Paediatr. 2003 Jun;92(6):721-7. — View Citation
Lau C. Development of infant oral feeding skills: what do we know? Am J Clin Nutr. 2016 Feb;103(2):616S-21S. doi: 10.3945/ajcn.115.109603. Epub 2016 Jan 20. — View Citation
Mathew OP. Respiratory control during nipple feeding in preterm infants. Pediatr Pulmonol. 1988;5(4):220-4. doi: 10.1002/ppul.1950050408. — View Citation
Meier P, Patel AL, Wright K, Engstrom JL. Management of breastfeeding during and after the maternity hospitalization for late preterm infants. Clin Perinatol. 2013 Dec;40(4):689-705. doi: 10.1016/j.clp.2013.07.014. Epub 2013 Sep 21. — View Citation
Mizuno K, Ueda A. Changes in sucking performance from nonnutritive sucking to nutritive sucking during breast- and bottle-feeding. Pediatr Res. 2006 May;59(5):728-31. doi: 10.1203/01.pdr.0000214993.82214.1c. — View Citation
Poets CF, Langner MU, Bohnhorst B. Effects of bottle feeding and two different methods of gavage feeding on oxygenation and breathing patterns in preterm infants. Acta Paediatr. 1997 Apr;86(4):419-23. doi: 10.1111/j.1651-2227.1997.tb09034.x. — View Citation
Sakalidis VS, Geddes DT. Suck-Swallow-Breathe Dynamics in Breastfed Infants. J Hum Lact. 2016 May;32(2):201-11; quiz 393-5. doi: 10.1177/0890334415601093. Epub 2015 Aug 28. — View Citation
Simmer K, Kok C, Nancarrow K, Hepworth AR, Geddes DT. Novel feeding system to promote establishment of breastfeeds after preterm birth: a randomized controlled trial. J Perinatol. 2016 Mar;36(3):210-5. doi: 10.1038/jp.2015.184. Epub 2015 Dec 10. — View Citation
Ward, N. Feeding and Swallowing Disorders in Infancy: Assessment and Management. J. Hum. Lact. 11, 147-147 (1995)
Whyte R. Safe discharge of the late preterm infant. Paediatr Child Health. 2010 Dec;15(10):655-66. doi: 10.1093/pch/15.10.655. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluating the level of coordination in the sucking-swallowing-breathing pattern in the B-ESP group compared with the B-STD | This evaluation will be recorded at 24 and 72 hours of life and defined from the suckings/swallowings ratio.
The literature describes this parameter as strongly associated to a higher maturity of the sucking-swallowing-breathing pattern; in fact, a ratio of sucking-swallowing-breathing of 1:1:1 describes the mature pattern, typical of the breastfeeding and considered the optimum for a newborn. |
Calculated throughout 72 hours | |
Secondary | Coefficient of variation of time between sucking and swallowing | This coefficient is expressed in seconds. a lower coefficient corresponds to breastfeeding | Calculated throughout 72 hours | |
Secondary | Mean percentage of incidence of breaths that precede and follow the swallowings | This percentage is classified by Lau et al. (the average interval between two breathing acts monitored during a meal of an healthy at term newborn varies between 1.2-2 seconds) | Calculated throughout 72 hours | |
Secondary | Evaluation of the sucking processes | This evaluation is made through the a structured questionnaire composed by 31 items | Calculated throughout 72 hours | |
Secondary | Evaluation of cardiorespiratory stability | This evaluation is made considering frequency and characteristics of cardiorespiratory events (during and after meal administration) | Calculated throughout 72 hours | |
Secondary | Evaluation of meal tolerance | This evaluation is carried out considering the number of vomiting and regurgitations during and after the meal, volume in mL per meal, number of meals per day | Calculated throughout 72 hours | |
Secondary | Number of breastfed newborns at the time of dimission | Calculated throughout 72 hours |
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