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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01989871
First received: November 6, 2013
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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 .


Condition Intervention
Body Weight Changes
Feeding and Eating Disorders of Childhood
Breast Feeding
Evoked Response Audiometry
Behavioral: Adjusted individual feeding

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • length of hospitalization [ Time Frame: between 36-40 weeks gestational age ] [ Designated as safety issue: No ]
    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:
  • age at reaching full oral feedings [ Time Frame: between 34-38 gestational age ] [ Designated as safety issue: No ]
    the age at which no nasogastric tube was used


Other Outcome Measures:
  • Griffith's developmental scales [ Time Frame: 6 month corrected age ] [ Designated as safety issue: No ]
    Griffith's developmental scales (Gross and fine motor, speech and language, performance and social skills)

  • weekly weight gain [ Time Frame: 33- 36 weeks gestational age ] [ Designated as safety issue: No ]
    weekly weight gain gr/kg will be calculated at 33 weeks gestational age, at 34, 35, and 36 weeks

  • parental anxiety [ Time Frame: 6 month corrected age ] [ Designated as safety issue: No ]
    parents anxiety will be assessed by a questioner


Estimated Enrollment: 60
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: protocol feeding
Feeding of preterm infants according to current unit protocol: every 3 hours a prescribed amount
Experimental: Adjusted individual feeding
Feeding every 2-4 hours, starting with que of hunger and finished upon infant signs.
Behavioral: Adjusted individual feeding
Feeding every 2-4 hours, starting with ques of hunger and finished upon infant signs.

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

  Eligibility

Ages Eligible for Study:   25 Weeks to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- birth at less than 32 weeks of gestation

Exclusion Criteria:

  • High grade intraventricular hemorrhage (grade 3 or4)
  • genetic syndrome
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01989871

Contacts
Contact: Iris Morag, MD +526479996 irismorag@gmail.com
Contact: tzipi Strauss, MD +526664446 t.tzipi@gmail.com

Locations
Israel
Sheba Medical Center Not yet recruiting
Ramat Gan, Israel, 52621
Contact: Iris Morag, MD    +526479996    irismorag@gmail.com   
Contact: Tzipi Strauss, MD    +526664446      
Principal Investigator: Iris Morag, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Iris Morag, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01989871     History of Changes
Other Study ID Numbers: SHEBA-12-9574-IM-CTIL
Study First Received: November 6, 2013
Last Updated: November 14, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
preterm
oral feeding
outcome

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Eating Disorders
Feeding and Eating Disorders of Childhood
Signs and Symptoms
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on July 23, 2014