Very Low Birth Weight InfantNCT03594474
Early Higher Intravenous Lipid Intake in VLBW Infants
A study testing Intravenous lipid emulsion in people with Very Low Birth Weight Infant, run by Belal Alshaikh at 1 site in Canada.
Trial summary
Provision of high and early fat intake may help to reduce the amount of postnatal weight loss in Very Low Birth Weight Infants. It may also help utilize the high amount of protein that is currently recommended to these premature babies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Very Low Birth Weight Infant
- What is being tested?
- Intravenous lipid emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteCanada
- Study dates
- 15 Aug 2018to 19 Oct 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm infants born with birth weight < 1500 g
- Appropriate for gestational age (AGA)
- Anticipated duration of PN for >7 days
Who cannot join
- Infants with congenital anomalies
- Infants with suspected inborn errors of metabolism or family history of inborn error of metabolism
- Infants with suspected or confirmed biliary atresia
- Infants born small for gestational age (SGA)
- Confirmed early sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Early Higher Intravenous Lipid Intake Decrease Weight Loss in Very Low Birth Weight Infants?
Provision of high and early fat intake may help to reduce the amount of postnatal weight loss in Very Low Birth Weight Infants. It may also help utilize the high amount of protein that is currently recommended to these premature babies. Also, we expect babies who get this appropriate intake to regain their birth weight earlier than others who are on slow fat increase regimen.
Read the detailed description
The recommendation of the Pediatric Societies of North America and Europe is that postnatal growth of preterm infants matches the in-utero growth rates of fetuses that remain in utero until full-term. Despite this long-standing recommendation, approximately 43% to 97% of very low birth weight (VLBW, less than 1500 g) infants grow slower than the estimated fetal growth velocity. This slow postnatal growth usually results in extra-uterine growth restriction (EUGR), defined as having a measured growth parameter (weight, length, or head circumference) that is less than 10th percentile of intrauterine growth expectation based on estimated postmenstrual age (PMA) in premature neonates at the time of hospital discharge.4 EUGR is associated with major morbidities such as bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP) and impaired neurodevelopment.
Although the etiology of EUGR is multifactorial, inadequate nutrition plays a pivotal role. There are three critical stages of nutrition support in VLBW infants: (1) acute stage during the first 1-3 weeks after birth when infants are on parenteral nutrition, (2) intermediate period when infants are slowly advanced to full enteral nutrition (growing care stage), and (3) the post-discharge stage. Failure to provide adequate nutrition in the acute stage result in cumulative energy and protein deficits that is difficult to reverse in the second stage. Inadequate early postnatal nutrition results in excessive weight loss that cannot be explained by the physiologic contraction of body water alone. The regain of birth weight may need two to three weeks or even longer in preterm infants with excessive postnatal weight loss.
Newborn infants born at term normally lose 5-10% of their body weight in the first week of life due to contraction of extracellular water compartment. The proportion of weight loss is significantly higher in VLBW infants. Increased insensible water loss is widely considered as the main cause for additional weight loss in this population. Nevertheless, studies identified low energy intake to be a key driver to excessive weight loss. In fact, an earlier study showed that significant postnatal weight loss occurs mainly in infants whose energy intake is inadequate. A more recent epidemiologic study demonstrated similar postnatal growth trajectories with a minimal crossing of percentiles after the initial weight loss regardless of gestational age at birth. The growth trajectories for infants in that study had similar slopes and growth rates which indicate that proportion of postnatal weight loss is a lead cause for EUGR at discharge. Therefore, we speculate that decreasing the maximum percentage of initial weight loss in the acute stage would keep the preterm infant on a higher growth trajectory that is enough to reduce the incidence of EUGR.
Current fat provision regimen for preterm infants include starting parenteral lipid at 12-24 hours of age with 0.5-1 g/kg per day and advancing by 0.5 g/kg/day until reaching 3 g/kg per day. Using early (within one hour of birth) and higher (start at 2 g/kg per day and advance to 3g/kg per day once total fluid intake is increased to 80 ml/kg/day) parenteral fat intake could reduce the cumulative caloric deficit in the acute stage. Because of high-density energy in fat, higher parenteral fat intake will reduce the early energy deficit and enhance protein accretion. The first 2-3 weeks of life offer a critical window to limit postnatal nutritional and energy deficits. Recent study showed that higher energy and fat intakes during the first 2 weeks after birth are associated with a lower incidence of brain lesions and dysmaturation at term equivalent age in preterm neonates.
To date, studies of "early aggressive nutrition" in preterm infants have mainly focused on high protein intake to prevent protein catabolism. Nevertheless, provision of high protein intake without enough energy is unlikely to significantly reduce the early loss of protein and fat mass that had been accreted before birth.
- Conditions
- Very Low Birth Weight Infant
- Being tested
- Intravenous lipid emulsion
- Keywords
- intravenous fat emulsions, preterm infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous lipid emulsionOther
Also called Intralipid
using higher dose of IV lipids after birth
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Begins treatment with 0.5 g/kg per day of 20% Intravenous Lipid Emulsion (IVLE) after birth if the birth weight is less or equal 1000g or 1 g/kg per day if birth weight is more than 1000g. The IVLE dose in this group will be increased by 0.5 g/kg per day daily until reaching 3 g/kg per day. |
| experimental group | Experimental | The experimental group will begin treatment with 2 g/kg per day of 20% Intravenous Lipid Emulsion after birth.
The dose of IVLE will be increased directly from 2 to 3 g/kg per day the next day in this group. Receives: Other: Intravenous lipid emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum percentage of weight loss
(birth weight-lowest postnatal weight)/birth weight× 100).
Measured: Until patient regains birth weight, on average within 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start15 Aug 2018
- Primary completion8 Jul 2019
- Study completion19 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Very Low Birth Weight InfantStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belal Alshaikh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Belal Alshaikh, University of Calgary
- Investigators
- Belal Alshaikh, MD,MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594474
- Sponsor's protocol ID
- REB17-2236
- Status last verified
- Nov 2020
- First submitted
- 9 Jul 2018
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alburaki W, Yusuf K, Dobry J, Sheinfeld R, Alshaikh B. High Early Parenteral Lipid in Very Preterm Infants: A Randomized-Controlled Trial. J Pediatr. 2021 Jan;228:16-23.e1. doi: 10.1016/j.jpeds.2020.08.024. Epub 2020 Aug 13.
PubMed 32798567
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Early Higher Intravenous Lipid Intake Decrease Weight Loss in Very Low Birth Weight Infants?
- ClinicalTrials.gov ID
- NCT03594474
- Acronym / sponsor ID
- REB17-2236
- Conditions
- Very Low Birth Weight Infant
- Keywords
- intravenous fat emulsions, preterm infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Belal AlshaikhUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 8 Jul 2019 (actual)
- Study completion
- 19 Oct 2019 (actual)
- First posted
- 20 Jul 2018 (actual)
- 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.
Provision of high and early fat intake may help to reduce the amount of postnatal weight loss in Very Low Birth Weight Infants. It may also help utilize the high amount of protein that is currently recommended to these premature babies. Also, we expect babies who get this appropriate intake to regain their birth weight earlier than others who are on slow fat increase regimen.
Detailed description
The recommendation of the Pediatric Societies of North America and Europe is that postnatal growth of preterm infants matches the in-utero growth rates of fetuses that remain in utero until full-term. Despite this long-standing recommendation, approximately 43% to 97% of very low birth weight (VLBW, less than 1500 g) infants grow slower than the estimated fetal growth velocity. This slow postnatal growth usually results in extra-uterine growth restriction (EUGR), defined as having a measured growth parameter (weight, length, or head circumference) that is less than 10th percentile of intrauterine growth expectation based on estimated postmenstrual age (PMA) in premature neonates at the time of hospital discharge.4 EUGR is associated with major morbidities such as bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP) and impaired neurodevelopment.
Although the etiology of EUGR is multifactorial, inadequate nutrition plays a pivotal role. There are three critical stages of nutrition support in VLBW infants: (1) acute stage during the first 1-3 weeks after birth when infants are on parenteral nutrition, (2) intermediate period when infants are slowly advanced to full enteral nutrition (growing care stage), and (3) the post-discharge stage. Failure to provide adequate nutrition in the acute stage result in cumulative energy and protein deficits that is difficult to reverse in the second stage. Inadequate early postnatal nutrition results in excessive weight loss that cannot be explained by the physiologic contraction of body water alone. The regain of birth weight may need two to three weeks or even longer in preterm infants with excessive postnatal weight loss.
Newborn infants born at term normally lose 5-10% of their body weight in the first week of life due to contraction of extracellular water compartment. The proportion of weight loss is significantly higher in VLBW infants. Increased insensible water loss is widely considered as the main cause for additional weight loss in this population. Nevertheless, studies identified low energy intake to be a key driver to excessive weight loss. In fact, an earlier study showed that significant postnatal weight loss occurs mainly in infants whose energy intake is inadequate. A more recent epidemiologic study demonstrated similar postnatal growth trajectories with a minimal crossing of percentiles after the initial weight loss regardless of gestational age at birth. The growth trajectories for infants in that study had similar slopes and growth rates which indicate that proportion of postnatal weight loss is a lead cause for EUGR at discharge. Therefore, we speculate that decreasing the maximum percentage of initial weight loss in the acute stage would keep the preterm infant on a higher growth trajectory that is enough to reduce the incidence of EUGR.
Current fat provision regimen for preterm infants include starting parenteral lipid at 12-24 hours of age with 0.5-1 g/kg per day and advancing by 0.5 g/kg/day until reaching 3 g/kg per day. Using early (within one hour of birth) and higher (start at 2 g/kg per day and advance to 3g/kg per day once total fluid intake is increased to 80 ml/kg/day) parenteral fat intake could reduce the cumulative caloric deficit in the acute stage. Because of high-density energy in fat, higher parenteral fat intake will reduce the early energy deficit and enhance protein accretion. The first 2-3 weeks of life offer a critical window to limit postnatal nutritional and energy deficits. Recent study showed that higher energy and fat intakes during the first 2 weeks after birth are associated with a lower incidence of brain lesions and dysmaturation at term equivalent age in preterm neonates.
To date, studies of "early aggressive nutrition" in preterm infants have mainly focused on high protein intake to prevent protein catabolism. Nevertheless, provision of high protein intake without enough energy is unlikely to significantly reduce the early loss of protein and fat mass that had been accreted before birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Begins treatment with 0.5 g/kg per day of 20% Intravenous Lipid Emulsion (IVLE) after birth if the birth weight is less or equal 1000g or 1 g/kg per day if birth weight is more than 1000g. The IVLE dose in this group will be increased by 0.5 g/kg per day daily until reaching 3 g/kg per day. |
| experimental group | Experimental | Other: Intravenous lipid emulsionThe experimental group will begin treatment with 2 g/kg per day of 20% Intravenous Lipid Emulsion after birth. The dose of IVLE will be increased directly from 2 to 3 g/kg per day the next day in this group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Preterm infants born with birth weight < 1500 g
- Appropriate for gestational age (AGA)
- Anticipated duration of PN for >7 days
Key exclusion criteria (5 listed)
- Infants with congenital anomalies
- Infants with suspected inborn errors of metabolism or family history of inborn error of metabolism
- Infants with suspected or confirmed biliary atresia
- Infants born small for gestational age (SGA)
- Confirmed early sepsis
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 |
|---|---|---|
| Intravenous lipid emulsionAlso: Intralipidusing higher dose of IV lipids after birth | Other | experimental group |
Primary outcome
The maximum percentage of weight loss
Time frame: Until patient regains birth weight, on average within 14 days
(birth weight-lowest postnatal weight)/birth weight× 100).
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 21 Dec 2021.
- Derived from this study: PubMed 32798567Alburaki W, Yusuf K, Dobry J, Sheinfeld R, Alshaikh B. High Early Parenteral Lipid in Very Preterm Infants: A Randomized-Controlled Trial. J Pediatr. 2021 Jan;228:16-23.e1. doi: 10.1016/j.jpeds.2020.08.024. Epub 2020 Aug 13.
- Individual participant dataSharing planned: No
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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.
Belal Alshaikh, MD,MSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous lipid emulsion in people with Very Low Birth Weight Infant, run by Belal Alshaikh at 1 site in Canada.
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 5 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 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The maximum percentage of weight loss (time frame: Until patient regains birth weight, on average within 14 days). 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 NCT03594474, which also lists 1 linked publication.
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 21 Dec 2021.