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

NCT01989871 | Unknown

• 1 other identifier: SHEBA-12-9574-IM-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 .

Conditions

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

Keywords

preterm; oral feeding; outcome

Outcome Measures

Primary Outcomes (1)

• length of hospitalization

  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

  between 36-40 weeks gestational age

Secondary Outcomes (1)

• age at reaching full oral feedings

  between 34-38 gestational age

Other Outcomes (3)

• Griffith's developmental scales

  6 month corrected age

• weekly weight gain

  33- 36 weeks gestational age

• parental anxiety

  6 month corrected age

Study Arms (2)

protocol feeding

NO INTERVENTION

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

Adjusted individual feeding

EXPERIMENTAL

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

Behavioral: Adjusted individual feeding

Interventions

Adjusted individual feeding BEHAVIORAL

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

Adjusted individual feeding

Eligibility Criteria

• Age: 25 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- birth at less than 32 weeks of gestation

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Body Weight Changes; Feeding and Eating Disorders of Childhood; Breast Feeding; Premature Birth

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding and Eating Disorders; Mental Disorders; Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Iris Morag, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Morag, MD

CONTACT

+526479996; irismorag@gmail.com

tzipi Strauss, MD

CONTACT

+526664446; t.tzipi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 21, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

IL (1)