Individualized Fortification of Breast Milk

NCT03324126 | Completed

• 1 other identifier: 35496
• Study Type: observational
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives: To compare the effects of two different methods of individualized protein fortification of breast milk on the early growth of VLBW preterm infants. Design: VLBW preterm infants ≤ 32 weeks of gestational age were included in the study and randomized into two groups according to the method of breast milk fortification. In the targeted protein fortification group, breast milk samples were analyzed daily via mid-infrared spectroscopy and additional protein was provided to maintain an intake of 4.5 g/kg/day. In the adjustable protein fortification group, blood urea nitrogen (BUN) levels were monitored weekly, and if the level was \< 5 mg/dL, the amount of protein fortification was gradually increased to an "estimated" maximum level of 4.5 g/kg/day, as per the policy of neonatal intensive care unit. The cumulative amounts of protein, energy, fat, and carbohydrate given to infants prior to study commencement and during the study period were calculated. Anthropometric measurements were performed in both groups weekly for 4 weeks to compare their growth, and blood data including pH, base deficit, and urea, creatinine, and albumin levels were collected.

Conditions

Breast Milk; Premature Infant

Keywords

Preterm infants; very low birth weight; breast milk; individualized fortification; targeted protein fortification; adjustable protein fortification; growth

Outcome Measures

Primary Outcomes (3)

• Weight gain

  The mean of weight gain (g/kg/day)

  4 weeks

• Head circumference

  The mean of head circumference (mm/week)

  4 weeks

• Length

  The mean of length (mm/week)

  4 weeks

Secondary Outcomes (8)

• Blood Urea Nitrogen (BUN)

  4 weeks

• Albumin

  4 weeks

• Base deficit

  4 weeks

• Protein content

  4 weeks

• Calorie intake

  4 weeks

Study Arms (2)

Targeted fortification

In the targeted protein fortification group, breast milk samples were analyzed daily via mid-infrared spectroscopy and additional protein was provided to maintain an intake of 4.5 g/kg/day.

Adjustable fortification

In the adjustable protein fortification group, blood urea nitrogen (BUN) levels were monitored weekly, and if the level was \< 5 mg/dL, the amount of protein fortification was gradually increased to an "estimated" maximum level of 4.5 g/kg/day

Eligibility Criteria

• Age: 25 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Very-low-birth-weight preterm infants ≤ 32 weeks of gestational age were included in the study and randomized into two groups according to the method of breast milk fortification.

You may qualify if:

• \- Very-low-birth-weight preterm infants ≤ 32 weeks of gestational age who were fed exclusively fortified breast milk.

Sponsors & Collaborators

• Ozgul Bulut: lead

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Zeynep Ince, Prof.

  Istanbul University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2017
• First Posted: October 27, 2017
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: February 28, 2014
• Last Updated: October 27, 2017

Record last verified: 2017-10