PUFA Supplementation in Premature Infants

• Sponsor: NorthShore University HealthSystem (Other)
• Overall Status: Completed
• CT.gov ID: NCT01955044
• Collaborator: Ann & Robert H Lurie Children's Hospital of Chicago (Other), Feinberg School of Medicine, Northwestern University (Other), Mead Johnson Nutrition (Industry)
• Enrollment: 30
• Locations: 3
• Arms: 3
• Duration (Months): 31
• Patients Per Site: 10
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants.

Condition or Disease	Intervention/Treatment	Phase
Premature, Extremely Low Birth Weight Infants; Polyunsaturated Fatty Acid Levels	Dietary Supplement: LCPUFA supplement; Dietary Supplement: placebo	N/A

Detailed Description

This will be a multi-center, randomized, placebo controlled, double blind trial.

Two doses of PUFA will be compared to placebo- a "high" dose and a "low" dose.

ELBW infants will be enrolled into this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Early DHA Supplementation in Extremely Low Birth Weight Infants
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: "high" dose LCPUFA the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants.	Dietary Supplement: LCPUFA supplement; Other Names: PUFA supplement
Experimental: "low" dose LCPUFA the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants.	Dietary Supplement: LCPUFA supplement; Other Names: PUFA supplement
Placebo Comparator: placebo the "placebo" is a drop that will be administered to ELBW infants.	Dietary Supplement: placebo

Outcome Measures

Primary Outcome Measures

1. Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels [2 weeks of life]

   LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants

Secondary Outcome Measures

1. LCPUFA Levels [8 weeks of life]

   LCPUFA levels will be measured at 8 weeks of life.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 72 Hours
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 1. Premature infant born at gestational age less than 34 weeks
• 1. Birth weight less than 1000 grams
• 1. Legally authorized representative is able to provide written informed consent within the first 72 hours of life, prior to the performance of an protocol-specified evaluations or procedures

Exclusion Criteria:

• 1. infants with known metabolic disorder
• 1. infants with known congenital gastrointestinal anomaly
• 1. infants who are deemed to be inappropriate for enrollment per attending neonatologist

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lurie Children's Hospital of Chicago	Chicago	Illinois	United States	60611
2	Prentice Women's Hospital	Chicago	Illinois	United States	60611
3	NorthShore University HealthSystem	Evanston	Illinois	United States	60201

Sponsors and Collaborators

• NorthShore University HealthSystem
• Ann & Robert H Lurie Children's Hospital of Chicago
• Feinberg School of Medicine, Northwestern University
• Mead Johnson Nutrition

Investigators

• Principal Investigator: Michael S Caplan, MD, NorthShore University HealthSystem

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brandy Frost, Attending Neonatologist, Clinician Educator, NorthShore University HealthSystem
• ClinicalTrials.gov Identifier: NCT01955044
• Other Study ID Numbers: EH13-334
• First Posted: Oct 7, 2013
• Last Update Posted: Sep 5, 2021
• Last Verified: Aug 1, 2021

• Keywords provided by Brandy Frost, Attending Neonatologist, Clinician Educator, NorthShore University HealthSystem: neonatal prematurity; infant, extremely low birth weight; fatty acids, polyunsaturated
• Additional relevant MeSH terms: Premature Birth; Birth Weight

Study Results

Participant Flow

Arm/Group Title	"High" Dose LCPUFA	"Low" Dose LCPUFA	Placebo
Arm/Group Description	the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	the "placebo" is a drop that will be administered to ELBW infants. placebo
Period Title: Overall Study
STARTED	10	10	10
COMPLETED	9	9	10
NOT COMPLETED	1	1	0

Baseline Characteristics

Arm/Group Title	"High" Dose LCPUFA	"Low" Dose LCPUFA	Placebo	Total
Arm/Group Description	the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	the "placebo" is a drop that will be administered to ELBW infants. placebo	Total of all reporting groups
Overall Participants	10	10	10	30
Age (Count of Participants)
<=18 years	10 100%	10 100%	10 100%	30 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	2 20%	5 50%	4 40%	11 36.7%
Male	8 80%	5 50%	6 60%	19 63.3%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	10 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels
Description	LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants
Time Frame	2 weeks of life

Outcome Measure Data

Analysis Population Description

2 subjects died prior to having 2 week levels drawn, from causes unrelated to study.

Arm/Group Title	"High" Dose LCPUFA	"Low" Dose LCPUFA	Placebo
Arm/Group Description	the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	the "placebo" is a drop that will be administered to ELBW infants. placebo
Measure Participants	9	9	10
2 week DHA levels	4.45	4.02	5.27
2 week ARA (arachidonic acid) levels	20.3	19.3	21.58

2. Secondary Outcome

Title	LCPUFA Levels
Description	LCPUFA levels will be measured at 8 weeks of life.
Time Frame	8 weeks of life

Outcome Measure Data

Analysis Population Description

2 subjects died prior to having 8 week levels drawn, from causes unrelated to study.

Arm/Group Title	"High" Dose LCPUFA	"Low" Dose LCPUFA	Placebo
Arm/Group Description	the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement	the "placebo" is a drop that will be administered to ELBW infants. placebo
Measure Participants	9	9	10
8 week DHA levels	5.52	5.58	6.75
8 week ARA levels	19.79	19.9	22.21

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	"High" Dose LCPUFA, "Low" Dose LCPUFA, Placebo
	Comments	DHA levels
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	1.23
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	"High" Dose LCPUFA		"Low" Dose LCPUFA		Placebo
Arm/Group Description	the "high" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement		the "low" dose LCPUFA supplement is a drop that will be administered to ELBW infants. LCPUFA supplement		the "placebo" is a drop that will be administered to ELBW infants. placebo
All Cause Mortality
	"High" Dose LCPUFA		"Low" Dose LCPUFA		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	"High" Dose LCPUFA		"Low" Dose LCPUFA		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		1/10 (10%)		0/10 (0%)
Gastrointestinal disorders
death	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0
spontaneous bowel perforation	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0
Respiratory, thoracic and mediastinal disorders
death	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0
Other (Not Including Serious) Adverse Events
	"High" Dose LCPUFA		"Low" Dose LCPUFA		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.