ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 287078 for:    ALL
Previous Study | Return to List | Next Study

Early Exclusive Enteral Nutrition in Early 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03708068
Recruitment Status : Not yet recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Belal Alshaikh, University of Calgary

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.

Condition or disease Intervention/treatment Phase
Enteral Nutrition Other: Early exclusive enteral nutrition Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Early Exclusive Enteral Nutrition in Stable Preterm Infants at 30 0/7 - 33 6/7 Weeks Gestation: A Randomized Controlled Trial
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Early Exclusive Enteral Nutrition

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.

Other: Early exclusive enteral nutrition
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.
Other Name: Early Total Enteral Feed

No Intervention: Conventional Enteral Nutrition

Infants will be fed as per current Neonatal Intensive Care Unit feeding tables:

  1. 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.
  2. 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.



Primary Outcome Measures :
  1. Duration to achieve of full enteral feeds in days [ Time Frame: Till 30 days of life ]
    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 :
  1. Length of hospital stay [ Time Frame: At discharge from neonatal intensive care unit (NICU), up to 90 days of life ]
    Length of hospital stay in days

  2. Feeding intolerance [ Time Frame: Till 30 days of life ]

    Presence of one or more of the following:

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

  3. Incidence of late onset sepsis [ Time Frame: At discharge from NICU, up to 90 days of life ]
    Any microbial growth in blood, cerebrospinal fluid or urine after 72 hours of admission in NICU

  4. Incidence of NEC [ Time Frame: At discharge from NICU, up to 90 days of life ]
    Any Stage II and above according to Bell's staging criteria

  5. Incidence of hypoglycemia [ Time Frame: Till 30 days of life ]
    Defined as point of care testing Glucose < 2.6 mmol/L at any time after rollment in study



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Preterm infants born at 30 0/7 - 33 6/7 weeks gestation
  2. Birth weight greater than 1000 g
  3. Consent to use donor human milk
  4. Postnatal age is less than 48 hours from birth
  5. 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:

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

Information from the National Library of Medicine

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): NCT03708068


Contacts
Contact: Belal Alshaikh, MD 403-956-1588 balshaik@ucalgary.ca

Locations
Canada, Alberta
Peter Lougheed Hospital Not yet recruiting
Calgary, Alberta, Canada, T1Y6J4
Contact: Belal Alshaikh, MD         
Sub-Investigator: Essa Al Awad, MD         
Sub-Investigator: Nalini Singhal, MD         
Foothills Medical Centre Not yet recruiting
Calgary, Alberta, Canada, T2N2T9
Contact: Belal Alshaikh, MD         
Principal Investigator: Belal Alshaikh, MD         
Sub-Investigator: Dinesh Dharel, MD         
Rockyview General Hospital Not yet recruiting
Calgary, Alberta, Canada, T2V1P9
Contact: Belal Alshaikh, MD         
Sub-Investigator: Jeanne Scotland, NNP         
South Health Campus Not yet recruiting
Calgary, Alberta, Canada, T3M1P9
Contact: Belal Alshaikh, MD         
Principal Investigator: Belal Alshaikh, MD         
Sub-Investigator: Ruma Jain, MD         
Sponsors and Collaborators
Belal Alshaikh
Investigators
Principal Investigator: Belal Alshaikh, MD University of Calgary

Responsible Party: Belal Alshaikh, Neonatologist, University of Calgary
ClinicalTrials.gov Identifier: NCT03708068     History of Changes
Other Study ID Numbers: REB18-0772
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Belal Alshaikh, University of Calgary:
Exclusive Enteral Nutrition, Early Preterm Infants