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Effects of Prefeeding Oral Stimulation on Feeding Performance in Preterm Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01649362
First Posted: July 25, 2012
Last Update Posted: March 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Luxembourg Institute of Health
Information provided by (Responsible Party):
Dr Manon BACHE, Centre Hospitalier du Luxembourg
  Purpose
The objective of this study is to evaluate the efficacy of an oral stimulation program on the length of the transition period in preterm infants (primary outcome), the length of hospital stay and the breastfeeding rates at discharge (secondary outcomes).

Condition Intervention
Preterm Infant Oral Feeding Performance Other: prefeeding oral stimulation program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Prefeeding Oral Stimulation on Feeding Performance in Preterm Infants Born Between 26 and 33+6 Weeks' Gestational Age: a Case-control Study

Further study details as provided by Dr Manon BACHE, Centre Hospitalier du Luxembourg:

Primary Outcome Measures:
  • Length of Transition Period [ Time Frame: participants were followed from date of randomization until full enteral feeding was acquired,an expected average of 5 weeks ]
    transition period was defined as the period from the introduction of enteral feeding to full enteral feeding


Secondary Outcome Measures:
  • Length of Hospital Stay [ Time Frame: participants were followed for the duration of hospital stay, an expected average of 5 weeks ]
  • Breastfeeding Rate at Discharge [ Time Frame: hospital discharge, an expected average of 5 weeks from the beginning of oral feeding introduction ]

Enrollment: 101
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group

No prefeeding oral stimulation

Infants in the control group received neither oral stimulation nor a pacifier before or during gavage feeding.

Experimental: Oral stimulation, interventional group

Infants in the interventional group received pre-feeding oral stimulation. The intervention started on infants born within 32 gestational weeks when the patients were stable and tube-fed, receiving more than 100 ml/kg/day of milk. On infants born after 32 weeks, the intervention started immediately after clinical stability was achieved.

The pre-feeding oral stimulation program consisted of a 15-minute stimulation program delivered by one of the eight trained nurses or one trained member from the medical staff in accordance with the stimulation program proposed by Fucile, Gisel and Lau.

The stimulation program was administered 15 to 30 minutes prior to tube feeding, once daily for at least 10 days. The program was stopped when the infants attained more than three oral feedings per day. The program was interrupted if the infants were medically unstable and/or had episodes of desaturation, apnoea and/or bradycardia during the intervention

Other: prefeeding oral stimulation program

The intervention will start at 32 weeks PMA in a medically stable infant feed by gavage feeding for the infants born before 32 weeks' gestational age, and, as soon as clinical stability is acquired, for the infants born after 32 weeks.

The prefeeding oral stimulation program consists of a 15-minute stimulation program, delivered by the nurse or the medical staff, according to the stimulation program proposed by Fucile, Gisel and Lau. The program is going to be administered once a day for 14 consecutive days (for infants born before 32 weeks' gestational age), 15 to 30 minutes before a tube feeding. In infants born after 32 weeks' gestational age, stimulation program is going to be stopped when the infant attains 3 complete oral feedings by day.


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  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • preterm infants from 26 to 33+6 weeks' gestational age, as determined by date of last menstruation and first-trimester ultrasound, hospitalized in our neonatal unit.

Exclusion Criteria:

  • Congenital malformations (chromosomal disorders, malformations of head and face, neurological, cardiac, digestive or pulmonary malformations)
  • Severe asphyxia (hypoxic-ischemic encephalopathy)
  • Presence of third or fourth degree intracranial haemorrhage
  • Severe periventricular leukomalacia
  • Severe chronic lung disease
  • Severe hospital infection during the study period
  • Necrotising enterocolitis during the study period
  • Feeding interruption for more than 10 days during the study period
  • Death during the study period
  • Transfer to another hospital before discharge.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649362


Locations
Luxembourg
Service de néonatologie, Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg, 1210
Sponsors and Collaborators
Centre Hospitalier du Luxembourg
Luxembourg Institute of Health
Investigators
Study Chair: Marie-Lise Lair Luxembourg Institute of Health
  More Information

Publications:
Amaizu N, Shulman R, Schanler R, Lau C. Maturation of oral feeding skills in preterm infants. Acta Paediatr. 2008 Jan;97(1):61-7. Epub 2007 Dec 3.
Arvedson J, Clark H, Lazarus C, Schooling T, Frymark T. Evidence-based systematic review: effects of oral motor interventions on feeding and swallowing in preterm infants. Am J Speech Lang Pathol. 2010 Nov;19(4):321-40. doi: 10.1044/1058-0360(2010/09-0067). Epub 2010 Jul 9. Review.
Barlow SM, Finan DS, Lee J, Chu S. Synthetic orocutaneous stimulation entrains preterm infants with feeding difficulties to suck. J Perinatol. 2008 Aug;28(8):541-8. doi: 10.1038/jp.2008.57. Epub 2008 Jun 12.
Bingham PM, Ashikaga T, Abbasi S. Prospective study of non-nutritive sucking and feeding skills in premature infants. Arch Dis Child Fetal Neonatal Ed. 2010 May;95(3):F194-200. doi: 10.1136/adc.2009.164186. Epub 2009 Nov 29.
Boiron M, Da Nobrega L, Roux S, Henrot A, Saliba E. Effects of oral stimulation and oral support on non-nutritive sucking and feeding performance in preterm infants. Dev Med Child Neurol. 2007 Jun;49(6):439-44.
Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. Erratum in: J Pediatr 2002 Nov;141(5):743.
Fucile S, Gisel EG, Lau C. Effect of an oral stimulation program on sucking skill maturation of preterm infants. Dev Med Child Neurol. 2005 Mar;47(3):158-62.
Pickler RH, Reyna BA. Effects of non-nutritive sucking on nutritive sucking, breathing, and behavior during bottle feedings of preterm infants. Adv Neonatal Care. 2004 Aug;4(4):226-34.
Pimenta HP, Moreira ME, Rocha AD, Gomes Jr SC, Pinto LW, Lucena SL. Effects of non-nutritive sucking and oral stimulation on breastfeeding rates for preterm, low birth weight infants: a randomized clinical trial. J Pediatr (Rio J). 2008 Sep-Oct;84(5):423-7. doi: doi:10.2223/JPED.1839. English, Portuguese.
Pinelli J, Symington A. Non-nutritive sucking for promoting physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD001071. Review. Update in: Cochrane Database Syst Rev. 2016 Oct 04;10 :CD001071.
Poore M, Zimmerman E, Barlow SM, Wang J, Gu F. Patterned orocutaneous therapy improves sucking and oral feeding in preterm infants. Acta Paediatr. 2008 Jul;97(7):920-7. doi: 10.1111/j.1651-2227.2008.00825.x. Epub 2008 May 7.
Rocha AD, Moreira ME, Pimenta HP, Ramos JR, Lucena SL. A randomized study of the efficacy of sensory-motor-oral stimulation and non-nutritive sucking in very low birthweight infant. Early Hum Dev. 2007 Jun;83(6):385-8. Epub 2006 Sep 18.
Stumm S, Barlow SM, Estep M, Lee J, Cannon S, Carlson J, Finan D. Respiratory Distress Syndrome Degrades the Fine Structure of the Non-Nutritive Suck In Preterm Infants. J Neonatal Nurs. 2008;14(1):9-16.
Lau C. [Development of oral feeding skills in the preterm infant]. Arch Pediatr. 2007 Sep;14 Suppl 1:S35-41. Review. French.

Responsible Party: Dr Manon BACHE, Paediatrician, Centre Hospitalier du Luxembourg
ClinicalTrials.gov Identifier: NCT01649362     History of Changes
Other Study ID Numbers: 201105/04
First Submitted: July 18, 2012
First Posted: July 25, 2012
Results First Submitted: October 29, 2013
Results First Posted: December 18, 2013
Last Update Posted: March 12, 2014
Last Verified: February 2014

Keywords provided by Dr Manon BACHE, Centre Hospitalier du Luxembourg:
preterm infant
feeding difficulties
prefeeding oral stimulation

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications


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