Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm Infants
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01989871|
Recruitment Status : Unknown
Verified November 2013 by Sheba Medical Center.
Recruitment status was: Not yet recruiting
First Posted : November 21, 2013
Last Update Posted : November 21, 2013
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 or disease||Intervention/treatment||Phase|
|Body Weight Changes Feeding and Eating Disorders of Childhood Breast Feeding Evoked Response Audiometry||Behavioral: Adjusted individual feeding||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2015|
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.
- length of hospitalization [ Time Frame: between 36-40 weeks gestational age ]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
- age at reaching full oral feedings [ Time Frame: between 34-38 gestational age ]the age at which no nasogastric tube was used
- Griffith's developmental scales [ Time Frame: 6 month corrected age ]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 ]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 ]parents anxiety will be assessed by a questioner
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989871
|Contact: Iris Morag, MDemail@example.com|
|Contact: tzipi Strauss, MDfirstname.lastname@example.org|
|Sheba Medical Center||Not yet recruiting|
|Ramat Gan, Israel, 52621|
|Contact: Iris Morag, MD +526479996 email@example.com|
|Contact: Tzipi Strauss, MD +526664446|
|Principal Investigator: Iris Morag, MD|
|Principal Investigator:||Iris Morag, MD||Sheba Medical Center|