Effects of Prefeeding Oral Stimulation on Feeding Performance in Preterm Infants

NCT01649362 | Completed Results

• 1 other identifier: 201105/04
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Preterm Infant; Oral Feeding Performance

Keywords

preterm infant; feeding difficulties; prefeeding oral stimulation

Outcome Measures

Primary Outcomes (1)

• Length of Transition Period

  transition period was defined as the period from the introduction of enteral feeding to full enteral feeding

  participants were followed from date of randomization until full enteral feeding was acquired,an expected average of 5 weeks

Secondary Outcomes (2)

• Length of Hospital Stay

  participants were followed for the duration of hospital stay, an expected average of 5 weeks

• Breastfeeding Rate at Discharge

  hospital discharge, an expected average of 5 weeks from the beginning of oral feeding introduction

Study Arms (2)

Control group

NO INTERVENTION

No prefeeding oral stimulation Infants in the control group received neither oral stimulation nor a pacifier before or during gavage feeding.

Oral stimulation, interventional group

EXPERIMENTAL

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

Interventions

prefeeding oral stimulation program OTHER

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.

Oral stimulation, interventional group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier du Luxembourg: lead
• Luxembourg Institute of Health: collaborator

Study Sites (1)

Service de néonatologie, Centre Hospitalier de Luxembourg

Luxembourg, 1210, Luxembourg

Location

Related Publications (14)

• Amaizu N, Shulman R, Schanler R, Lau C. Maturation of oral feeding skills in preterm infants. Acta Paediatr. 2008 Jan;97(1):61-7. doi: 10.1111/j.1651-2227.2007.00548.x. Epub 2007 Dec 3.

  PMID: 18052999 BACKGROUND

• 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.

  PMID: 20622046 BACKGROUND

• 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.

  PMID: 18548084 BACKGROUND

• 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.

  PMID: 19948525 BACKGROUND

• 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. doi: 10.1111/j.1469-8749.2007.00439.x.

  PMID: 17518930 BACKGROUND

• 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. doi: 10.1067/mpd.2002.125731.

  PMID: 12183719 BACKGROUND

• 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. doi: 10.1017/s0012162205000290.

  PMID: 15739719 BACKGROUND

• 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. doi: 10.1016/j.adnc.2004.05.005.

  PMID: 15368215 BACKGROUND

• Pimenta HP, Moreira ME, Rocha AD, Gomes SC Jr, 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: 10.2223/JPED.1839. English, Portuguese.

  PMID: 18923786 BACKGROUND

• 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. doi: 10.1002/14651858.CD001071.pub2.

  PMID: 16235279 BACKGROUND

• 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.

  PMID: 18462468 BACKGROUND

• 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. doi: 10.1016/j.earlhumdev.2006.08.003. Epub 2006 Sep 18.

  PMID: 16979854 BACKGROUND

• 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. doi: 10.1016/j.jnn.2007.11.001.

  PMID: 19122873 BACKGROUND

• Lau C. [Development of oral feeding skills in the preterm infant]. Arch Pediatr. 2007 Sep;14 Suppl 1:S35-41. doi: 10.1016/s0929-693x(07)80009-1. French.

  PMID: 17939956 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Dr Manon Bache
• Organization: Centre Hospitalier de Luxembourg

manon.bache@hotmail.com

+352 4411 3157

Study Officials

• Marie-Lise Lair

  Luxembourg Institute of Health

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paediatrician

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: July 25, 2012
• Study Start: June 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 12, 2014
• Results First Posted: December 18, 2013

Record last verified: 2014-02

Locations

LU (1)