Effects of Prefeeding Oral Stimulation on Feeding Performance in Preterm Infants

This study has been completed.
Sponsor:
Collaborator:
CRP-Santé Luxembourg
Information provided by (Responsible Party):
Dr Manon BACHE, Centre Hospitalier du Luxembourg
ClinicalTrials.gov Identifier:
NCT01649362
First received: July 18, 2012
Last updated: February 9, 2014
Last verified: February 2014
  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:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Breastfeeding Rate at Discharge [ Time Frame: hospital discharge, an expected average of 5 weeks from the beginning of oral feeding introduction ] [ 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

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.


  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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
Results First Received: October 29, 2013
Last Updated: February 9, 2014
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 August 19, 2014