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Early Exclusive Enteral Nutrition in Early Preterm Infants

Primary Purpose

Enteral Nutrition

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Early exclusive enteral nutrition

About this trial

This is an interventional other trial for Enteral Nutrition focused on measuring Exclusive, Enteral Nutrition, Preterm Infant

Eligibility Criteria

undefined - 48 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Preterm infants born at 30 0/7 - 33 6/7 weeks gestation
Birth weight greater than 1000 g
Consent to use donor human milk
Postnatal age is less than 48 hours from birth
Infant is ready to start on feeding (as per clinical team) or feeding volume, when already started, is ≤12 ml/kg per day (total) and/or the infant received ≤2 feeds based on current feeding policy or physician descrition (total volume of the received feeds is ≤20 ml/kg per day).

Exclusion Criteria:

Cord PH < 7.00 or Cord base access (BE) < -16
Apgar score < 7 at 5 minute
Lactate level ≥3 (if done for clinical indication)
Need for positive pressure ventilation (PPV) for >1 minute.
Hemodynamic instability (hypotension or poor perfusion at any time in this 48 hours)
Small for gestational age <3 percentile on Fenton chart and/or fetal absent or reversed umbilical arterial end-diastolic blood flow.
Major congenital malformation
Symptomatic or severe hypoglycemia (blood glucose <1.8 mmol/L)
Infants with moderate to severe respiratory distress.

Sites / Locations

Peter Lougheed HospitalRecruiting
Foothills Medical CentreRecruiting
South Health CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early Exclusive Enteral Nutrition

Conventional Enteral Nutrition

Arm Description

Feeds will start at least at 80% of reference daily fluid intake from day one of life. Feeds will be advanced by 20-30 ml/kg per day on second day onwards until infant reaches full enteral feed.

Infants will be fed as per current Neonatal Intensive Care Unit feeding tables: Infants with birth weight 1000-1500 g will be fed on 15-20 ml/kg human milk in day one. Feeds will be advanced by 15-20 ml/kg per day on second day onwards until infant reaches full enteral feeds. Infants with birth weight >1500 g will be started on 20-30 ml/kg per day on day one. Feeds will be advanced by 20-30 ml/kg per day on second day onwards until infant reaches full enteral feeds.

Outcomes

Primary Outcome Measures

Duration to achieve of full enteral feeds in days

Day of life to achieve full enteral feeding defined as 140 ml/kg/day which is sustained for at least 3 days

Secondary Outcome Measures

Length of hospital stay

Length of hospital stay in days

Feeding intolerance

Presence of one or more of the following: vomiting more than 2 times during any 24 h period, any episode of bile- or blood-stained vomiting, abdominal wall erythema or tenderness that resulted in cessation of feed.

Incidence of late onset sepsis

Any microbial growth in blood, cerebrospinal fluid or urine after 72 hours of admission in NICU

Incidence of NEC

Any Stage II and above according to Bell's staging criteria

Incidence of hypoglycemia

Defined as point of care testing Glucose < 2.6 mmol/L at any time after rollment in study

Full Information

NCT ID

NCT03708068

First Posted

October 1, 2018

Last Updated

December 19, 2021

Sponsor

Belal Alshaikh

1. Study Identification

Unique Protocol Identification Number

NCT03708068

Brief Title

Early Exclusive Enteral Nutrition in Early Preterm Infants

Official Title

Early Exclusive Enteral Nutrition in Stable Preterm Infants at 30 0/7 - 33 6/7 Weeks Gestation: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 16, 2019 (Actual)

Primary Completion Date

November 2022 (Anticipated)

Study Completion Date

November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Belal Alshaikh

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Enteral nutrition in preterm infants is usually started and advanced slowly until reaching full enteral feeds. Most preterm infants born before 34 weeks gestation require parenteral fluids to maintain normal blood sugar level and prevent excessive weight loss and dehydration. Availability of donor human milk (DHM) along with low incidence of necrotizing enterocolitis (NEC) in preterm infants born at 30-33 weeks have encouraged neonatologists to start feeding early and advance it faster in order to shorten time on parenteral nutrition (PN) and minimize the need for intravenous access. The objectives of this trial is to study whether exclusive enteral nutrition from day of birth (i.e. no PN) results in shorter time to achieve full enteral feed when compared with traditional feeding regimen that involves a combination of PN and progressive enteral feeding.

Detailed Description

Early nutritional support of preterm infants born at 30-33 weeks gestation is usually achieved via a combination of parenteral nutrition (PN) and enteral feeding that is advanced over few days to reach full enteral feed. Recent studies suggest that rapid increase of enteral feed volumes results in shorter duration on PN and earlier achievement of full enteral feed without increasing the risk of necrotizing enterocolitis (NEC) or death. Although PN has an important role in nutrition of preterm infants, it is associated with increased risk of metabolic and infectious complications even when it is used for a short period of time. Furthermore, PN mandates the need for peripheral or central intravenous access. Provision of full enteral feed volume that meets reference daily fluid intake from day of birth is used frequently and successfully in stable preterm infants born after 33 weeks. Expanding the use of this regimen to stable preterm infants born at 30-33 weeks gestation may help avoid unnecessary start of intravenous access, prevent complications related to PN, and encourage mother-infant bonding experience.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Enteral Nutrition

Keywords

Exclusive, Enteral Nutrition, Preterm Infant

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early Exclusive Enteral Nutrition

Arm Type

Experimental

Arm Description

Feeds will start at least at 80% of reference daily fluid intake from day one of life. Feeds will be advanced by 20-30 ml/kg per day on second day onwards until infant reaches full enteral feed.

Arm Title

Conventional Enteral Nutrition

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

Early exclusive enteral nutrition

Other Intervention Name(s)

Early Total Enteral Feed

Intervention Description

Infants will be fed at least 80% of reference daily fluid intake from day one. Feeds will be advanced by 20-30 ml/kg per day on second day onwards to meet reference daily fluid intake until infant reaches full enteral feed.

Primary Outcome Measure Information:

Title

Duration to achieve of full enteral feeds in days

Description

Day of life to achieve full enteral feeding defined as 140 ml/kg/day which is sustained for at least 3 days

Time Frame

Till 30 days of life

Secondary Outcome Measure Information:

Title

Length of hospital stay

Description

Length of hospital stay in days

Time Frame

At discharge from neonatal intensive care unit (NICU), up to 90 days of life

Title

Feeding intolerance

Description

Time Frame

Till 30 days of life

Title

Incidence of late onset sepsis

Description

Any microbial growth in blood, cerebrospinal fluid or urine after 72 hours of admission in NICU

Time Frame

At discharge from NICU, up to 90 days of life

Title

Incidence of NEC

Description

Any Stage II and above according to Bell's staging criteria

Time Frame

At discharge from NICU, up to 90 days of life

Title

Incidence of hypoglycemia

Description

Defined as point of care testing Glucose < 2.6 mmol/L at any time after rollment in study

Time Frame

Till 30 days of life

10. Eligibility

Sex

All

Maximum Age & Unit of Time

48 Hours

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Preterm infants born at 30 0/7 - 33 6/7 weeks gestation Birth weight greater than 1000 g Consent to use donor human milk Postnatal age is less than 48 hours from birth Infant is ready to start on feeding (as per clinical team) or feeding volume, when already started, is ≤12 ml/kg per day (total) and/or the infant received ≤2 feeds based on current feeding policy or physician descrition (total volume of the received feeds is ≤20 ml/kg per day). Exclusion Criteria: Cord PH < 7.00 or Cord base access (BE) < -16 Apgar score < 7 at 5 minute Lactate level ≥3 (if done for clinical indication) Need for positive pressure ventilation (PPV) for >1 minute. Hemodynamic instability (hypotension or poor perfusion at any time in this 48 hours) Small for gestational age <3 percentile on Fenton chart and/or fetal absent or reversed umbilical arterial end-diastolic blood flow. Major congenital malformation Symptomatic or severe hypoglycemia (blood glucose <1.8 mmol/L) Infants with moderate to severe respiratory distress.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Belal Alshaikh, MD

Phone

403-956-1588

balshaik@ucalgary.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Belal Alshaikh, MD

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peter Lougheed Hospital

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T1Y6J4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Belal Alshaikh, MD

First Name & Middle Initial & Last Name & Degree

Essa Al Awad, MD

First Name & Middle Initial & Last Name & Degree

Nalini Singhal, MD

Facility Name

Foothills Medical Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N2T9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Belal Alshaikh, MD

First Name & Middle Initial & Last Name & Degree

Belal Alshaikh, MD

First Name & Middle Initial & Last Name & Degree

Dinesh Dharel, MD

Facility Name

South Health Campus

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3M1P9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Belal Alshaikh, MD

First Name & Middle Initial & Last Name & Degree

Belal Alshaikh, MD

First Name & Middle Initial & Last Name & Degree

Ruma Jain, MD

12. IPD Sharing Statement

Learn more about this trial

Early Exclusive Enteral Nutrition in Early Preterm Infants

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