Recruiting

Hindmilk

Sponsor:

Belal Alshaikh

Code:

NCT03637413

Conditions

Weight Gain

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Hindmilk

Study Details

Brief summary:

Research question: Does feeding hindmilk improve weight gain in very preterm infants with poor growth velocity?

Hypothesis: In very preterm infants (born less than 32 weeks gestation) with poor postnatal growth velocity (<15 g/kg/day), feeding hindmilk would improve average weight gain by at least 4 g/kg per day.

Study design: This will be a prospective cohort study in very preterm infants admitted to the Neonatal Intensive Care Unit (NICU) at Foothills Medical Centre

Conditions

Weight Gain

Study ID

NCT03637413

Start date

Jan 22, 2019

Status verified date

Nov, 2022

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Very preterm infant ( <32 weeks at birth)
  • On full enteral feeds for more than 2 weeks (full feed is defined at the time of reaching 120 ml/kg/day with no parenteral nutrition used)
  • Poor weight gain (<15 g/kg per day) despite optimization of energy and protein intakes by RDs (calories intake: 125-135 Kcal/kg per day and protein: 4-4.5 g/kg per day)
  • Mothers have enough milk supply (>150% of infant's daily needs)

Exclusion Criteria

  • Congenital anomalies
  • Small for gestational age infants (< 10th percentile) at birth

Study Design

Enrollment

34 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hindmilk

Hindmilk, the milk at the end of a breast pumping session, has higher fat and energy content compared to the composite milk.

Interventions

Hindmilk

Mother will be taught to separate her milk and infant will receive only hindmilk for feeds

Primary outcome measure

  • Average Weight Gain [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Belal Alshaikh, MD, MSc

403-955-2320belal.alshaikh@ahs.ca

Zainab Towage, MD

zainab.towage@ahs.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N2T9

Contacts

Belal Alshaikh, MD, MSc

403-955-2320belal.alshaikh@ahs.ca

Zainab Towage, MD

zainab.towage@ahs.ca

Principal Investigator:

Belal Alshaikh, MD, MSc

More Information

Sponsor

Belal Alshaikh

Last update posted

Nov 7, 2022

Last verified

Nov, 2022

Keywords

  • preterm infants
  • hindmilk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Belal Alshaikh on 2022-11-07.