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

NCT ID: NCT01989871

Last Updated: 2013-11-21

Basic Information

• 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

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intervention group will be taught be the nurses (NIDCAP trainees) to identify their infants' ques (self regulation or withdrawn as well as signs of hunger), This parents will be taught the physiology of maturation of feeding, as well as various techniques of infants feeding amongst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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Adjusted individual feeding

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iris Morag, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Central Contacts

Iris Morag, MD

Role: CONTACT

irismorag@gmail.com

+526479996

tzipi Strauss, MD

Role: CONTACT

t.tzipi@gmail.com

+526664446

Facility Contacts

Iris Morag, MD

Role: primary

irismorag@gmail.com

+526479996

Tzipi Strauss, MD

Role: backup

+526664446

Other Identifiers

SHEBA-12-9574-IM-CTIL

Identifier Type: -

Identifier Source: org_study_id