Effects of Prefeeding Oral Stimulation on Feeding Performance in Preterm Infants - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Breast Feeding Premature Babies

U.S. FDA Resources

Further study details as provided by Centre Hospitalier du Luxembourg:

Primary Outcome Measures:

length of transition period [ Time Frame: participants will be followed for date of randomization until full enteral feeding is acquried,an expected average of 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

length of hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: No ]
Breastfeeding rate at discharge [ Time Frame: discharge ] [ Designated as safety issue: No ]

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
Experimental: oral stimulation preterm infants receiving an prefeeding oral stimulation program	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.

Arms

Assigned Interventions

No Intervention: control group

no prefeeding oral stimulation

Experimental: oral stimulation

preterm infants receiving an prefeeding oral stimulation program

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.

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649362

Locations

Luxembourg
Service de néonatologie, Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg, 1210

Sponsors and Collaborators

Centre Hospitalier du Luxembourg

CRP-Santé Luxembourg

Investigators

Study Chair:

Marie-Lise Lair

CRP-Santé Luxembourg

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. 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. 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. 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. 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.

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. 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
Study First Received:	July 18, 2012
Last Updated:	April 29, 2013
Health Authority:	Luxembourg: Comite National d'Ethique de Recherche

Keywords provided by Centre Hospitalier du Luxembourg:

preterm infant
feeding difficulties
prefeeding oral stimulation

ClinicalTrials.gov processed this record on May 16, 2013