Effects of Prefeeding Oral Stimulation on Feeding Performance in Preterm Infants
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|ClinicalTrials.gov Identifier: NCT01649362|
Recruitment Status : Completed
First Posted : July 25, 2012
Results First Posted : December 18, 2013
Last Update Posted : March 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Preterm Infant Oral Feeding Performance||Other: prefeeding oral stimulation program||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||December 2012|
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.
- 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
- 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 ]
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
|Service de néonatologie, Centre Hospitalier de Luxembourg|
|Luxembourg, Luxembourg, 1210|
|Study Chair:||Marie-Lise Lair||Luxembourg Institute of Health|