Clinical trial NCT01989871: Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm Infants
Official title: Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Body Weight Changes
Feeding and Eating Disorders of Childhood
Breast Feeding
Evoked Response Audiometry
Keywords: preterm
oral feeding
outcome
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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 description: 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intervention group will be taught be the nurses (NIDCAP trainees) to identify their infants' ques (self regulation or withdrawn as well as signs of hunger), This parents will be taught the physiology of maturation of feeding, as well as various techniques of infants feeding amongst them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

Eligibility criteria: Inclusion Criteria:

- birth at less than 32 weeks of gestation

Exclusion Criteria:

* High grade intraventricular hemorrhage (grade 3 or4)
* genetic syndrome

Primary outcomes:
measure: length of hospitalization
timeFrame: between 36-40 weeks gestational age
Secondary outcomes:
measure: age at reaching full oral feedings
timeFrame: between 34-38 gestational age
Other outcomes:
measure: Griffith's developmental scales
timeFrame: 6 month corrected age
measure: weekly weight gain
timeFrame: 33- 36 weeks gestational age
measure: parental anxiety
timeFrame: 6 month corrected age
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Iris Morag, MD
role: PRINCIPAL_INVESTIGATOR
References: