Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02913677
Other study ID # ZTB7915
Secondary ID
Status Completed
Phase N/A
First received August 15, 2016
Last updated January 13, 2018
Start date September 2016
Est. completion date September 2017

Study information

Verified date August 2016
Source Zekai Tahir Burak Women's Health Research and Education Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Recent studies showed the benefits of early initiation and advancement enteral feeds with daily increments in preterm infants on decreasing invasive infections and early achievement of full enteral feedings. But the data on enteral feeds of extremely low birthweight infants are limited. Preterm infants especially those <1250 gr birthweight are at increased risk of developing feeding intolerance and necrotizing enterocolitis (NEC) and so the initiation and the rate of increments of enteral feeds are usually uncertain issues for neonatologists.


Description:

Background: Recent studies showed the benefits of early initiation and advancement enteral feeds with daily increments in preterm infants on decreasing invasive infections and early achievement of full enteral feedings. But the data on enteral feeds of extremely low birthweight infants are limited. Preterm infants especially those <1250 gr birthweight are at increased risk of developing feeding intolerance and necrotizing enterocolitis and so the initiation and the rate of increments of enteral feeds are usually uncertain issues for neonatologists.

Aim: To assess the effects of two different feeding strategies in very low birth weight preterm infants with birth weight ≤1250 gr and gestational age ≤32 weeks on the incidence of feeding intolerance and time to reach full enteral feedings.

Study design: prospective randomized controlled trial comparing the effects of prolonged minimal enteral nutrition (MEN) with progressive advancing enteral feedings.

Primary outcomes: incidence of feeding intolerance and time to reach full enteral feedings sustained for 72 hours.

Secondary outcomes: incidence of NEC, sepsis, duration of hospitalization Methods: a total of 200 preterm infants with gestational age ≤32 weeks and birthweight ≤1250 gr were randomly allocated to one of the 2 feeding strategies.

Group 1-) Feeding was started in the first 48 hours. Fed with 10-15 ml/kg/d MEN for 5 days and than feed volumes were advanced by 20-25 ml/kg/d until 150ml/kg/d feed volume was achieved.

Group 2-) Feeding was started in the first 48 hours with a volume of 10-15 ml/kg/d and advanced with daily increments of 20-25 ml/kg/d until 150 ml/kg/d feed volume was achieved.

MEN was withheld when the infant developped NEC or when there was bilious emesis or gross blood in stool.

Feeding intolerance was defined as; Bilious emesis or gastric residuals Grossly bloody stools, Abdominal tenderness or discoloration, Gastric residuals in ≥%50 of previous feed volume Emesis ≥3 times in 8 hours period Clinical or radiological evidence of NEC When feeding intolerance was developped feeds were withheld in both groups until the problem was resolved and resumed feed volume where withheld.

In the study unit parenteral nutrition was started on the first day of birth. Parenteral nutrition volume was decreased as the enteral feeds increased. Breast milk was the first choice for enteral nutrition if available but if not preterm formulas were used. When 100ml/kg/d enteral feed volume was achieved breast milk was fortified with Euprotin as a standard procedure.


Recruitment information / eligibility

Status Completed
Enrollment 199
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 23 Weeks to 32 Weeks
Eligibility Inclusion Criteria:

- gestational age=32 weeks and birthweight =1250 gr, and <48 hours postnatal age

Exclusion Criteria:

- Major congenital and/or chromosomal anomaly, Cyanotic congenital heart disease, Asphyxiated birth with pH <7.0 and base deficit =16mmol/l Severe cardiopulmonary compromise or multiorgan failure Twin-twin transfusion, Those died in postnatal 5 days of age

Study Design


Intervention

Dietary Supplement:
nutrition
Feeding was started in the first 48 hours. Fed with 10-15 ml/kg/d MEN for 5 days and than feed volumes were advanced by 20-25 ml/kg/d until 150ml/kg/d feed volume was achieved.

Locations

Country Name City State
Turkey Zekai Tahir Burak Women's Health and Education Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of feeding intolerance incidence of feeding intolerance 28 days
Primary time to reach full enteral feedings sustained for 72 hours. 72 hours
See also
  Status Clinical Trial Phase
Not yet recruiting NCT00916591 - Prokinetic Drugs and Enteral Nutrition N/A
Completed NCT01025167 - The Effect of a New Specific Enteral Formula Compared to a Standard Formula on the Tolerability of a Combined Radio- and Chemotherapy in Cancer Patients N/A
Not yet recruiting NCT05900323 - Enteral Nutrition Guidelines and Patients' Outcomes N/A
Completed NCT03153397 - Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial) N/A
Completed NCT02353689 - The Effect of FODMAP Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement Phase 2/Phase 3
Terminated NCT00564655 - Regional Anesthesia Block of the Transversus Abdominis Plane in Children Undergoing Gastric Tube Insertion Phase 3
Completed NCT06134674 - Early Versus Delayed Enteral Nutrition in Critically Ill Adults With COVID-19
Recruiting NCT03791866 - The Th9/IL-9 and Early Enteral Nutrition in Sepsis N/A
Enrolling by invitation NCT06161350 - The Multi-disciplinary Approach of Children With Feeding Difficulties and Tube Feeding in UZB Between 2000 and 2021
Active, not recruiting NCT02724631 - TubeClear® Evaluation in Pediatric Patients (Phase I) N/A
Completed NCT01988792 - Human Milk Fortification in Very Low Birth Neonates N/A
Completed NCT00600678 - Gastric Emptying Study After Administration of a High Caloric Sip Feed N/A
Completed NCT02998931 - Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients Phase 3
Not yet recruiting NCT06411873 - The Effect of High Protein Enteral Nutrition on Critically Ill Postoperative Children N/A
Recruiting NCT03176875 - Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-onset Crohn's Disease N/A
Completed NCT02779335 - Enteral Formula Tolerance in Pediatric Patients N/A
Completed NCT05411848 - 2kcal Tube Feed Study N/A
Completed NCT04868318 - The Impact of Intervention With High-protein Enteral Formula in SICU. N/A
Withdrawn NCT04601571 - Confirming Feeding Tube Position Using CORTRAK N/A
Not yet recruiting NCT06239610 - DrIFT 2 Study: Displacement in Feeding Tubes N/A