NCT02692521

Brief Summary

The purpose of this study is to discover the incentives and barriers to human milk use and breast-feeding in the NICU graduate. By better understanding the incentives and barriers we believe we can define better methods for promoting higher rates and longer duration of human milk use in this medically fragile population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,160

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

3.9 years

First QC Date

February 17, 2016

Last Update Submit

June 4, 2020

Conditions

Human Milk/Breastfeeding

Outcome Measures

Primary Outcomes (1)

  • Identify barriers and incentives to the use of human milk in infants hospitalized in a NICU

    Increase human milk use in post-NICU neonates by identifying barriers and incentives to the use of human milk in infants hospitalized in a NICU in order to maximize its use.

    2 years

Interventions

Human MilkDIETARY_SUPPLEMENT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

NICU Graduates

You may qualify if:

  • Survival to discharge
  • Site ability to plan and implement developmental follow-up for two years corrected age

You may not qualify if:

  • Parents unwilling to participate in follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Developmental Follow-up Clinic - Scottsdale / Kidz Clinic II

Scottsdale, Arizona, United States

Location

Summerlin Developmental Clinic

Las Vegas, Nevada, United States

Location

Dallas Developmental Pediatrics

Dallas, Texas, United States

Location

San Antonio Pediatric Development Services

San Antonio, Texas, United States

Location

Preemie Place High Risk Infant Follow-up Clinic

The Woodlands, Texas, United States

Location

Related Publications (6)

  • Briere CE, McGrath J, Cong X, Cusson R. An integrative review of factors that influence breastfeeding duration for premature infants after NICU hospitalization. J Obstet Gynecol Neonatal Nurs. 2014 May-Jun;43(3):272-81. doi: 10.1111/1552-6909.12297. Epub 2014 Apr 1.

    PMID: 24689979BACKGROUND

  • Davanzo R, Ronfani L, Brovedani P, Demarini S; Breastfeeding in Neonatal Intensive Care Unit Study Group. Breast feeding very-low-birthweight infants at discharge: a multicentre study using WHO definitions. Paediatr Perinat Epidemiol. 2009 Nov;23(6):591-6. doi: 10.1111/j.1365-3016.2009.01068.x.

    PMID: 19840296BACKGROUND

  • Furman L, Minich N, Hack M. Correlates of lactation in mothers of very low birth weight infants. Pediatrics. 2002 Apr;109(4):e57. doi: 10.1542/peds.109.4.e57.

    PMID: 11927730BACKGROUND

  • Paula P. Meier, RN, DNSc, FAAN, Janet L. Engstrom, RN, PhD, CNM, WHNP-BC, Aloka L. Patel, MD, Briana J. Jegier, PhD, and Nicholas E. Bruns, Improving the Use of Human Milk During and After the NICU Stay. BSPublished online February 27, 2012 4Pediatrics Vol. 129 No. 3 March 1, 2012 pp. e827-e841 doi: 10.1542/peds.2011-3552

    BACKGROUND

  • Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.

    PMID: 22371471BACKGROUND

  • Fenrich AL, Shmorhun DP, Martin GC, Young JA, Cohen MI, Kelleher AS, Anyebuno MA, Rider ED, Motta CL, Clark RH. Long QT and Hearing Loss in High-Risk Infants Prospective Study Registry. Pediatr Cardiol. 2022 Dec;43(8):1898-1902. doi: 10.1007/s00246-022-02939-4. Epub 2022 Jun 3.

    PMID: 35661239DERIVED

MeSH Terms

Interventions

Milk, Human

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Elaine Ellis, MD

    Pediatrix

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2016

First Posted

February 26, 2016

Study Start

March 1, 2016

Primary Completion

February 3, 2020

Study Completion

February 3, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations

US(5)