NCT02116699 is a NA clinical trial of oropharyngeal mother's milk in Infection, sponsored by Endeavor Health.

Who is sponsoring NCT02116699?

NCT02116699 is sponsored by Endeavor Health.

What drugs are being tested in NCT02116699?

Interventions in NCT02116699: oropharyngeal mother's milk, oropharyngeal sterile water.

What condition does NCT02116699 study?

NCT02116699 studies Infection, Enterocolitis, Necrotizing, Ventilator-associated Pneumonia.

Is NCT02116699 still recruiting?

NCT02116699 is currently completed. Last updated 1 March 2023.

Last reviewed 2023-03-01 · How we verify

NCT02116699

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)

Completed NA Last updated 1 March 2023

What this trial tests

NA trial testing oropharyngeal mother's milk in Infection in 260 participants. Completed in 4 January 2022.

Timeline

20 November 2013

Primary endpoint
30 October 2021

4 January 2022

Quick facts

Lead sponsor	Endeavor Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	260
Start date	20 November 2013
Primary completion	30 October 2021
Estimated completion	4 January 2022
Sites	5 locations across United States

Drugs / interventions tested

oropharyngeal mother's milk
oropharyngeal sterile water

Conditions studied

Infection — all drugs for Infection →
Enterocolitis, Necrotizing — all drugs for Enterocolitis, Necrotizing →
Ventilator-associated Pneumonia — all drugs for Ventilator-associated Pneumonia →

Sponsor

Endeavor Health — full company profile →

Who can join

Adults 1 Day to 4 Days, any sex, with Infection or Enterocolitis, Necrotizing. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Extremely premature (BW\<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide immunostimulatory effects when administered oropharyngeally to extremely premature infants during the first weeks of life. The investigators hypothesize that infants who receive oropharyngeal mother's colostrum and milk will have significantly lower rates of infection and improved health outcomes, compared to infants who receive a placebo.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Oropharyngeal administration of mother's colostrum, health outcomes of premature infants: study protocol for a randomized controlled trial.
Rodriguez NA, Vento M, Claud EC, Wang CE, et al · · 2015 · cited 38× · PMID 26458907 · DOI 10.1186/s13063-015-0969-6
Oropharyngeal Colostrum for Preterm Infants: A Systematic Review and Meta-Analysis.
Panchal H, Athalye-Jape G, Patole S. · · 2019 · cited 28× · PMID 31147686 · DOI 10.1093/advances/nmz033
A randomized controlled trial of oropharyngeal therapy with mother's own milk for premature infants.
Rodriguez NA, Moya F, Ladino J, Zauk A, et al · · 2023 · cited 6× · PMID 36596945 · DOI 10.1038/s41372-022-01589-x

Verify or expand the search:

Other recruiting trials for Infection

Currently open trials in the same condition.

NCT07358117 — Viral Infections of the Central Nervous System: Diagnosis and Clinical Outcome · active not recruiting
NCT07110636 — Microbial Cell-free Metagenomic Sequencing for Suspected Infections in Adult Immunocompromised Outpatients · NA · recruiting
NCT06806709 — Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial) · NA · recruiting
NCT06974162 — Metagenomics for Ocular Inflammation · recruiting
NCT07370948 — Study of the Antibiotic-resistance Profile of Enterobacterales Isolated From Rectal Mucosal Buffer of PrEP Subjects · recruiting

Other Endeavor Health trials

Trials by the same sponsor.

NCT06258785 — Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension · Phase 3 · completed
NCT06279195 — Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment · Phase 2 · withdrawn
NCT05921149 — Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer · NA · not yet recruiting
NCT05747027 — Prospective Randomized Controlled Trial of Obstructed Defecation Surgery · NA · terminated
NCT06062875 — Effects of TNF Blockade on Human BPH/LUTS · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02116699 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Endeavor Health
Last refreshed: 1 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02116699.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing