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

NCT ID: NCT01989871

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-12-31

Brief Summary

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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

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intervention group will be taught be the nurses (NIDCAP trainees) to identify their infants' ques (self regulation or withdrawn as well as signs of hunger), This parents will be taught the physiology of maturation of feeding, as well as various techniques of infants feeding amongst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

Conditions

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

Keywords

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preterm oral feeding outcome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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protocol feeding

Feeding of preterm infants according to current unit protocol: every 3 hours a prescribed amount

Group Type NO_INTERVENTION

No interventions assigned to this group

Adjusted individual feeding

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

Group Type EXPERIMENTAL

Adjusted individual feeding

Intervention Type BEHAVIORAL

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

Interventions

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Adjusted individual feeding

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\- birth at less than 32 weeks of gestation

Exclusion Criteria

* High grade intraventricular hemorrhage (grade 3 or4)
* genetic syndrome
Minimum Eligible Age

25 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Iris Morag, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Central Contacts

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Iris Morag, MD

Role: CONTACT

Phone: +526479996

Email: [email protected]

tzipi Strauss, MD

Role: CONTACT

Phone: +526664446

Email: [email protected]

Facility Contacts

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Iris Morag, MD

Role: primary

Tzipi Strauss, MD

Role: backup

Other Identifiers

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SHEBA-12-9574-IM-CTIL

Identifier Type: -

Identifier Source: org_study_id