Feeding BehaviorNCT02998489
Effectiveness and Safety of Fast Enteral Feeding in Preterm Infants Between 1000 and 2000 Grams of Birth Weight
A study testing Fast milk advancement and Traditional milk advancement in people with Feeding Behavior, run by Hospital Universitario San Ignacio.
Trial summary
This is a randomized controlled trial with infants less than 34 weeks and between 1000 and 2000 grams at birth, that seeks to establish the safety and effectiveness of fast enteral advancement (milk 30-40 cc/kg/d) compared with traditional advancement (milk 20 cc/kg/d) Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Feeding Behavior
- What is being tested?
- Fast milk advancement and Traditional milk advancement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2014to 12 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants less than 34 weeks of gestational age.
- Weight at birth between 1000 and 2000 grams.
- Infants hospitalized in the newborn unit at Hospital Universitario San Ignacio in Bogotá, Colombia.
Who cannot join
- Perinatal Asphyxia
- Intrauterine Growth Restriction
- Diagnosis of Congenital Hearth Disease
- Severe Hypoxemia
- Major Congenital Malformations
- Metabolic Disease
Show all 10Show fewer
- Intolerance to initiate oral feeding at the eligibility
- Patent Ductus with hemodynamic instability
- Early Onset Sepsis with hemodynamic instability
- Refusal of parents to participate in the study
About this study
Official title: Effectiveness and Safety of Rapid Enteral Feeding in Preterm Infants Between 1000 and 2000 Grams of Birth Weight
This is a randomized controlled trial with infants less than 34 weeks and between 1000 and 2000 grams at birth, that seeks to establish the safety and effectiveness of fast enteral advancement (milk 30-40 cc/kg/d) compared with traditional advancement (milk 20 cc/kg/d)
Read the detailed description
Progression of enteral feeding in preterm infants is still controversial. The neonatologist needs to provide adequate caloric intake avoiding the risk of food intolerance and necrotizing enterocolitis.
Objective: To establish the safety and effectiveness of fast enteral advancement compared with traditional advancement.
Design: A randomized controlled clinical trial with infants less than 34 weeks and between 1000 and 2000 grams at birth conducted at Hospital Universitario San Ignacio in Bogotá, Colombia.
Methods: 30 cc versus 20 cc / kg / day advancing in infants between 1000 and 1499g and 40cc versus 20 cc / kg / day advancing in infants between 1500 and 1999g.
Outcomes: days to reach full enteral nutrition, days of parenteral nutrition (PN) and/or intravenous fluids (IVF), days to regain birth weight, episodes of food intolerance, anthropometric measurements and weight gain at 40 weeks; rate of late onset sepsis, hypoglycemia, hyperbilirubinemia, necrotizing enterocolitis (NEC) and mortality. Data will be analyzed with Student t test or Mann-Whitney U-test and Pearson Chi-square or Fisher test. Multiple linear regression will be performed.
Ethics: This Protocol was approved by the Ethics and Research Committee of Pontificia Universidad Javeriana and San Ignacio Hospital. Informed consent will be requested to parents.
- Conditions
- Feeding Behavior
- Being tested
- Fast milk advancement, Traditional milk advancement
- Keywords
- enteral nutrition, infant,premature, feeding method
- Medical subject headings
- Feeding Behavior, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast milk advancementOther
Also called Milk
30-40 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved
Traditional milk advancementOther
Also called Milk
20 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved
| Study group | Role | What they receive |
|---|---|---|
| Fast milk advancement | Experimental | 30-40 cc/kg/d of human milk or formula milk administered by orogastric tube or by suction Receives: Other: Fast milk advancement |
| Traditional milk advancement | Active comparator | 20 cc/kg/d of human milk or formula milk administered by orogastric tube or by suction Receives: Other: Traditional milk advancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
days to reach full enteral nutrition
number of days employed to reach full enteral nutrition with breast milk, formula milk or breast milk plus formula milk.
Measured: number of days from date of randomization until the day that the baby reach full enteral nutrition or date of death from any cause assessed up to 12 weeks
days of intravenous fluids
number of days with intravenous fluids included parenteral nutrition and dextrose with electrolytes
Measured: number of days of intravenous fluids from birth until suspension of them or date of death from any cause assessed up to 12 weeks
Secondary outcomes (11)
days to regain birth weight
number of days employed to regain birth weight
Measured: number of days from birth, employed to regain birth weight or date of death from any cause assessed up to 12 weeks
episodes of food intolerance
number of episodes of food intolerance per day during hospitalization
Measured: number of episodes of food intolerance per day from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
weight at 40 weeks
weight in grams at 40 weeks of post menstrual age
Measured: weight at 40 weeks of post menstrual age
length at 40 weeks
length in centimeters at 40 weeks of post menstrual age
Measured: length at 40 weeks of post menstrual age
head circumference at 40 weeks
head circumference in centimeters at 40 weeks of post menstrual age
Measured: head circumference at 40 weeks of post menstrual age
weight gain per day at 40 weeks of post menstrual age
weight gain in gr./d from birth until 40 weeks of post menstrual age
Measured: weight gain in grams per day from birth until 40 weeks of post menstrual age
rate of necrotizing enterocolitis
rate of necrotizing enterocolitis through study completion
Measured: through study completion(from date of randomization until 40 weeks of post menstrual age)
rate of mortality
number of patients who died during the study's follow up
Measured: through study completion(from date of randomization until 40 weeks of post menstrual age)
rate of late onset sepsis
number of patients who had late onset sepsis during hospitalization
Measured: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
rate of hyperbilirubinemia
number of patients who had hyperbilirubinemia and were treated with phototherapy during hospitalization
Measured: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
rate of hypoglycemia
number of patients who had hypoglycemia during hospitalization
Measured: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start1 Apr 2014
- Primary completion31 Dec 2015
- Study completion12 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Feeding BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriana Montealegre, Dr., Principal investigator, Hospital Universitario San Ignacio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998489
- Sponsor's protocol ID
- 2014/25
- Status last verified
- Mar 2018
- First submitted
- 11 Dec 2016
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Morgan J, Young L, McGuire W. Slow advancement of enteral feed volumes to prevent necrotising enterocolitis in very low birth weight infants. Cochrane Database Syst Rev. 2015 Oct 15;(10):CD001241. doi: 10.1002/14651858.CD001241.pub6.
PubMed 26469124Moore TA, Wilson ME. Feeding intolerance: a concept analysis. Adv Neonatal Care. 2011 Jun;11(3):149-54. doi: 10.1097/ANC.0b013e31821ba28e.
PubMed 21730906
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Rapid Enteral Feeding in Preterm Infants Between 1000 and 2000 Grams of Birth Weight
- ClinicalTrials.gov ID
- NCT02998489
- Acronym / sponsor ID
- 2014/25
- Conditions
- Feeding Behavior
- Keywords
- enteral nutrition, infant,premature, feeding method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 12 Sep 2016 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial with infants less than 34 weeks and between 1000 and 2000 grams at birth, that seeks to establish the safety and effectiveness of fast enteral advancement (milk 30-40 cc/kg/d) compared with traditional advancement (milk 20 cc/kg/d)
Detailed description
Progression of enteral feeding in preterm infants is still controversial. The neonatologist needs to provide adequate caloric intake avoiding the risk of food intolerance and necrotizing enterocolitis.
Objective: To establish the safety and effectiveness of fast enteral advancement compared with traditional advancement.
Design: A randomized controlled clinical trial with infants less than 34 weeks and between 1000 and 2000 grams at birth conducted at Hospital Universitario San Ignacio in Bogotá, Colombia.
Methods: 30 cc versus 20 cc / kg / day advancing in infants between 1000 and 1499g and 40cc versus 20 cc / kg / day advancing in infants between 1500 and 1999g.
Outcomes: days to reach full enteral nutrition, days of parenteral nutrition (PN) and/or intravenous fluids (IVF), days to regain birth weight, episodes of food intolerance, anthropometric measurements and weight gain at 40 weeks; rate of late onset sepsis, hypoglycemia, hyperbilirubinemia, necrotizing enterocolitis (NEC) and mortality. Data will be analyzed with Student t test or Mann-Whitney U-test and Pearson Chi-square or Fisher test. Multiple linear regression will be performed.
Ethics: This Protocol was approved by the Ethics and Research Committee of Pontificia Universidad Javeriana and San Ignacio Hospital. Informed consent will be requested to parents.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast milk advancement | Experimental | Other: Fast milk advancement30-40 cc/kg/d of human milk or formula milk administered by orogastric tube or by suction |
| Traditional milk advancement | Active comparator | Other: Traditional milk advancement20 cc/kg/d of human milk or formula milk administered by orogastric tube or by suction |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants less than 34 weeks of gestational age.
- Weight at birth between 1000 and 2000 grams.
- Infants hospitalized in the newborn unit at Hospital Universitario San Ignacio in Bogotá, Colombia.
Key exclusion criteria (10 listed)
- Perinatal Asphyxia
- Intrauterine Growth Restriction
- Diagnosis of Congenital Hearth Disease
- Severe Hypoxemia
- Major Congenital Malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast milk advancementAlso: Milk30-40 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved | Other | Fast milk advancement |
| Traditional milk advancementAlso: Milk20 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved | Other | Traditional milk advancement |
Primary outcome
days to reach full enteral nutrition
Time frame: number of days from date of randomization until the day that the baby reach full enteral nutrition or date of death from any cause assessed up to 12 weeks
number of days employed to reach full enteral nutrition with breast milk, formula milk or breast milk plus formula milk.
days of intravenous fluids
Time frame: number of days of intravenous fluids from birth until suspension of them or date of death from any cause assessed up to 12 weeks
number of days with intravenous fluids included parenteral nutrition and dextrose with electrolytes
11 secondary outcomes
days to regain birth weight
Time frame: number of days from birth, employed to regain birth weight or date of death from any cause assessed up to 12 weeks
episodes of food intolerance
Time frame: number of episodes of food intolerance per day from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
weight at 40 weeks
Time frame: weight at 40 weeks of post menstrual age
length at 40 weeks
Time frame: length at 40 weeks of post menstrual age
head circumference at 40 weeks
Time frame: head circumference at 40 weeks of post menstrual age
weight gain per day at 40 weeks of post menstrual age
Time frame: weight gain in grams per day from birth until 40 weeks of post menstrual age
rate of necrotizing enterocolitis
Time frame: through study completion(from date of randomization until 40 weeks of post menstrual age)
rate of mortality
Time frame: through study completion(from date of randomization until 40 weeks of post menstrual age)
rate of late onset sepsis
Time frame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
rate of hyperbilirubinemia
Time frame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
rate of hypoglycemia
Time frame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Results publication: PubMed 26469124Morgan J, Young L, McGuire W. Slow advancement of enteral feed volumes to prevent necrotising enterocolitis in very low birth weight infants. Cochrane Database Syst Rev. 2015 Oct 15;(10):CD001241. doi: 10.1002/14651858.CD001241.pub6.
- Results publication: PubMed 21730906Moore TA, Wilson ME. Feeding intolerance: a concept analysis. Adv Neonatal Care. 2011 Jun;11(3):149-54. doi: 10.1097/ANC.0b013e31821ba28e.
- Individual participant dataSharing planned: No
Related trials for Feeding Behavior
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruiting
Effects of Environmental Comfort and Oral Motor Stimulation on Comfort and Oral Feeding Readiness in Preterm Infants
Prematurity, Feeding Behaviors
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Montealegre, Dr. principal investigator
Hospital Universitario San Ignacio
Questions about this trial
What is this clinical trial studying?
A study testing Fast milk advancement and Traditional milk advancement in people with Feeding Behavior, run by Hospital Universitario San Ignacio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
days to reach full enteral nutrition (time frame: number of days from date of randomization until the day that the baby reach full enteral nutrition or date of death from any cause assessed up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02998489, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.