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Completed

NCT Number: NCT03055052

Clinical Effects of a Formula With Modified Protein Levels and Fat Blend in Preterm Infants

This study evaluates the effects of infant formula with higher protein level and improved fat blend on growth and feeding tolerance in preterm infants. Half of the subjects will receive a standard infant formula, while the other half will receive a infant formula with a higher protein level and improved fat blend.

Completed

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Key information

Conditions

Infant, Premature, Nutrition Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 33 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tu Du Hospital

Ho Chi Minh City, Ho Chi Minh, Vietnam

About this study

When an infant is born prematurely, the supply of nutrients supporting normal growth and development is interrupted. There is less time to accrue adequate nutrient stores and foetal tissue. The nutritional goal for the preterm infant is to have satisfactory functional development and catch up on growth to match the rate of a full term infant. To achieve this, it is recommended for the infant to have adequate protein intake and suitable fat blend.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Less than or equal to 33 weeks 0 days
  • Birth weight less than or equal to 2000g.
  • Infant is anticipated to receive the study formula for ≥ 3 consecutive weeks
  • At entry into Full Enteral Feeding, study formula will be provided at 50% or more of total enteral feedings.
  • Written informed consent has been obtained from the parent/legally authorized representative (LAR).

Exclusion criteria

  • Peri-/intra-ventricular hemorrhage
  • Renal disease
  • Hepatic dysfunction
  • Major congenital malformations
  • Suspected or documented systemic or congenital infections
  • Cardiac, respiratory, endocrinologic, hematologic, GI, or other systemic diseases that may impact growth
  • Suspected or documented maternal substance abuse
  • Infants who have received any experimental treatment or intervention

Treatment and study plan

Standard formula for preterm infants

Other

Reconstituted in water and given to infants at more than 50% of feedings.

Formula with higher protein and new fat blend for preterm infants

Other

Reconstituted in water and given to infants at more than 50% of feedings.

Primary outcomes

  1. Growth in terms of weight gain per day

    Time frame: 21 days

Secondary outcomes

  1. Growth in terms of length and head circumference

    Time frame: Till infant reaches 3kg (study completion), expected within 3 months

  2. Feeding tolerance (frequency of regurgitation, stool frequency and consistency)

    Time frame: Till infant reaches 3kg (study completion), expected within 3 months

  3. Incidence of adverse events

    Time frame: 30 days post infant stopping study infant formula intake upon reaching 3kg

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 16, 2017
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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