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

Not Applicable

• Conditions: Body Weight Changes; Feeding and Eating Disorders of Childhood; Breast Feeding; Evoked Response Audiometry
• Interventions: Behavioral: Adjusted individual feeding

• Registration Number: NCT01989871
• Lead Sponsor: Sheba Medical Center

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intervention group will be taught be the nurses (NIDCAP trainees) to identify their infants' ques (self regulation or withdrawn as well as signs of hunger), This parents will be taught the physiology of maturation of feeding, as well as various techniques of infants feeding amongst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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2013-11
• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-11-14
• Last Update Submitted: 2013-11-14
• Study First Posted: 2013-11-21
• Last Update Posted: 2013-11-21
• Study Start: 2013-12
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• birth at less than 32 weeks of gestation

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Adjusted individual feeding	Adjusted individual feeding	Feeding every 2-4 hours, starting with que of hunger and finished upon infant signs.

Primary Outcome Measures

Name	Time	Method
length of hospitalization	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

Secondary Outcome Measures

Name	Time	Method
age at reaching full oral feedings	between 34-38 gestational age	the age at which no nasogastric tube was used

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel