Clinical Trial: Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm Infants

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm

Brief Summary:

The authors hypothesize that adjusted individual feeding (AIF) for preterm infant starting from transition to oral feeding (33 weeks corrected age) will result in less episodes of apnea/bradycardia, early achievement of full oral feeding, improved weight gain and shorten hospitalization duration in the short term.

In the long term AIF will result in higher scores on the Griffith's developmental scales, decreasing parental anxiety and feeding disorders .


Detailed Summary: Preterm infants born at <32 weeks of gestation at our institute will qualify for this study. Recruitment will occur between day 7-14 of life after sever brain malformations or intraventricular bleeding will be ruled out. Randomization to control or intervention will be via sealed envelopes. In the control group - infants will be treated according to the common practice in the neonatal intensive care unit. Transition to oral feeding will occur at 33 wkks (breast feeding) and 34 wks (bottle feeding). Meals will be given every 3 hours, the amount will be written by the care giving physician and will be written as a strict number (i.e 30 ml every 3 hours) Parents in the intervention group will be taught be the nurses (NIDCAP trainees) to identify their infants' ques (self regulation or withdrawn as well as signs of hunger), This parents will be taught the physiology of maturation of feeding, as well as various techniques of infants feeding amongst them pace feeding. During the study parents in both groups will be interviewed every 14 days as for their satisfactions, anxieties, infants ability to cope. video typing during Kangaroo care at 32 and 35 wks as well as during feeding at 35 weeks will be done and evaluated. General movements assessment (neurodevelopment) will be done at 33 -35 weeks gestational age, as well as at 52 weeks. Alberta infant motor scales will be evaluated at 4 and 8 month corrected age,Automated Brain stem evoked Response (ABR) will be done at 33 wks for assessment of brain stem maturity, duration of hospitalization, weight gain per week at 33, 34 and 35 weeks will be calculated, age at full oral feeding will be noted. At the age of 6 month Griffith's developmental scales will be performed
Sponsor: Sheba Medical Center

Current Primary Outcome: length of hospitalization [ Time Frame: between 36-40 weeks gestational age ]

length of hospitalization from admission to discharge, and length of stay beyond reaching 36 weeks corrected age , the time point at wich health infants are usually being discharged


Original Primary Outcome: Same as current

Current Secondary Outcome: age at reaching full oral feedings [ Time Frame: between 34-38 gestational age ]

the age at which no nasogastric tube was used


Original Secondary Outcome: Same as current

Information By: Sheba Medical Center

Dates:
Date Received: November 6, 2013
Date Started: December 2013
Date Completion: December 2015
Last Updated: November 14, 2013
Last Verified: November 2013