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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01989871
Enrollment
60
Registered
2013-11-21
Start date
2013-12-31
Completion date
2015-12-31
Last updated
2013-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Weight Changes, Breast Feeding, Evoked Response Audiometry, Feeding and Eating Disorders of Childhood

Keywords

preterm, oral feeding, outcome

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intervention group will be taught be the nurses (NIDCAP trainees) to identify their infants' ques (self regulation or withdrawn as well as signs of hunger), This parents will be taught the physiology of maturation of feeding, as well as various techniques of infants feeding amongst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

Interventions

BEHAVIORALAdjusted individual feeding

Feeding every 2-4 hours, starting with ques of hunger and finished upon infant signs.

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Weeks to 32 Weeks
Healthy volunteers
No

Inclusion criteria

\- birth at less than 32 weeks of gestation

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
length of hospitalizationbetween 36-40 weeks gestational agelength 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

MeasureTime frameDescription
age at reaching full oral feedingsbetween 34-38 gestational agethe age at which no nasogastric tube was used

Other

MeasureTime frameDescription
Griffith's developmental scales6 month corrected ageGriffith's developmental scales (Gross and fine motor, speech and language, performance and social skills)
weekly weight gain33- 36 weeks gestational ageweekly weight gain gr/kg will be calculated at 33 weeks gestational age, at 34, 35, and 36 weeks
parental anxiety6 month corrected ageparents anxiety will be assessed by a questioner

Countries

Israel

Contacts

Primary ContactIris Morag, MD
irismorag@gmail.com+526479996
Backup Contacttzipi Strauss, MD
t.tzipi@gmail.com+526664446

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026