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

Breast Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01989871
• Other study ID #: SHEBA-12-9574-IM-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: November 6, 2013
• Last updated: November 14, 2013
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2013
• Source: Sheba Medical Center
• Contact: Iris Morag, MD
• Phone: +526479996
• Email: irismorag[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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 .

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intervention group will be taught be the nurses (NIDCAP trainees) to identify their infants' ques (self regulation or withdrawn as well as signs of hunger), This parents will be taught the physiology of maturation of feeding, as well as various techniques of infants feeding amongst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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Weeks to 32 Weeks

Eligibility

Inclusion Criteria:

• birth at less than 32 weeks of gestation

Exclusion Criteria:

• High grade intraventricular hemorrhage (grade 3 or4)

• genetic syndrome

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Adjusted individual feeding
Feeding every 2-4 hours, starting with ques of hunger and finished upon infant signs.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Griffith's developmental scales	Griffith's developmental scales (Gross and fine motor, speech and language, performance and social skills)	6 month corrected age	No
Other	weekly weight gain	weekly weight gain gr/kg will be calculated at 33 weeks gestational age, at 34, 35, and 36 weeks	33- 36 weeks gestational age	No
Other	parental anxiety	parents anxiety will be assessed by a questioner	6 month corrected age	No
Primary	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	No
Secondary	age at reaching full oral feedings	the age at which no nasogastric tube was used	between 34-38 gestational age	No