NCT04400175

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

2.5 years

First QC Date

April 25, 2020

Last Update Submit

August 15, 2023

Conditions

Premature BirthFeeding; Difficult, NewbornFeeding, Bottle

Keywords

late-preterm newborns, valved feeding system

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Coefficient of variation of time between sucking and swallowing

    Calculated throughout 72 hours

  • Mean percentage of incidence of breaths that precede and follow the swallowings

    Calculated throughout 72 hours

  • Evaluation of the sucking processes

    Calculated throughout 72 hours

  • Evaluation of cardiorespiratory stability

    Calculated throughout 72 hours

  • Evaluation of meal tolerance

    Calculated throughout 72 hours

  • +1 more secondary outcomes

Study Arms (2)

B-ESP

EXPERIMENTAL

B-ESP group will be fed with a feeding system with a valved ergonomic teat.

Device: Valved ergonomic teat

B-STD

SHAM COMPARATOR

B-STD will be fed with a standard feeding system.

Device: Standard silicon teat

Interventions

Valved ergonomic teatDEVICE

Administration of milk with a feeding system with a valved ergonomic teat in late preterm newborns.

B-ESP
Standard silicon teatDEVICE

Administration of milk with a feeding system with a standard silicon teat

B-STD

Eligibility Criteria

Age1 Day - 5 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age 34+0 - 36+6 weeks at birth;
  • Exclusive oral feeding;
  • Bottle-feeding for at least a meal a day;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Città della Salute e della Scienza - Ospedale S.Anna - University of Turin

Turin, 10126, Italy

Location

Related Publications (19)

  • 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.

    PMID: 29054835BACKGROUND

  • 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.

    PMID: 9174231BACKGROUND

  • 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.

    PMID: 28324898BACKGROUND

  • 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.

    PMID: 11138220BACKGROUND

  • 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.

    PMID: 16940236BACKGROUND

  • 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.

    PMID: 26658121BACKGROUND

  • 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.

    PMID: 16627890BACKGROUND

  • Mathew OP. Respiratory control during nipple feeding in preterm infants. Pediatr Pulmonol. 1988;5(4):220-4. doi: 10.1002/ppul.1950050408.

    PMID: 3237449BACKGROUND

  • Ward, N. Feeding and Swallowing Disorders in Infancy: Assessment and Management. J. Hum. Lact. 11, 147-147 (1995)

    BACKGROUND

  • 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.

    PMID: 26319112BACKGROUND

  • 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.

    PMID: 27461200BACKGROUND

  • 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.

    PMID: 22131865BACKGROUND

  • 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.

    PMID: 24182956BACKGROUND

  • 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.

    PMID: 26791183BACKGROUND

  • 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.

    PMID: 22119233BACKGROUND

  • 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.

    PMID: 26964010BACKGROUND

  • 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.

    PMID: 20542296BACKGROUND

  • 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.

    PMID: 21962771BACKGROUND

  • Lau C, Smith EO, Schanler RJ. Coordination of suck-swallow and swallow respiration in preterm infants. Acta Paediatr. 2003 Jun;92(6):721-7.

    PMID: 12856985BACKGROUND

MeSH Terms

Conditions

Premature BirthBottle Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehavior

Study Officials

  • Francesco Cresi, MD; PhD

    Città della Salute e della Scienza - Ospedale S.Anna - University of Turin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2020

First Posted

May 22, 2020

Study Start

December 1, 2020

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Locations

IT(1)