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

NCT02116699 | Completed DMC

• 1 other identifier: EH11-360
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Infection; Enterocolitis, Necrotizing; Ventilator-associated Pneumonia

Keywords

oropharyngeal; colostrum; mother's milk; premature; neonate; infection; necrotizing enterocolitis; ventilator-associated pneumonia; breastmilk; human milk; late-onset sepsis; microbiome; antioxidant; enteral feeds

Outcome Measures

Primary Outcomes (3)

• Incidence of of late-onset sepsis

  positive blood cultures (not deemed contaminated) collected after 72 hours of age, and 2 clinical symptoms

  at 40 wks CGA

• Incidence of necrotizing enterocolitis

  defined according to modified Bell's criteria stage \>2 with clinical signs and radiological evidence of pneumatosis intestinalis or portal venous gas

  at 40 weeks CGA

• Incidence of ventilator-associated pneumonia

  at 40 weeks CGA

Secondary Outcomes (5)

• Time to reach full enteral feeds

  at 40 wks CGA

• Length of hospital stay

  at 40 wks CGA

• Concentrations of lactoferrin in urine

  1 day, 3 days, 32 weeks CGA

• Changes in stool microbiome

  3 days, 2 weeks, 32 weeks CGA

• Changes in urinary biomarkers of oxidative stress

  3 days,

Study Arms (2)

oropharyngeal mother's milk

EXPERIMENTAL

0.2 mL every 2 hours for 48 hours beginning within 96 hours post-birth, followed by 0.2 mL every 3 hours until 32 weeks post conceptional age

Other: oropharyngeal mother's milk

oropharyngeal sterile water

PLACEBO COMPARATOR

0.2 mL every 2 hours for 48 hours beginning within 96 hours post-birth, followed by 0.2 mL every 3 hours until 32 weeks post conceptional age

Other: oropharyngeal sterile water

Interventions

oropharyngeal mother's milk OTHER

Application of 0.2 mL of own mother's milk onto the infant's oral mucosa, for an initial treatment period of every 2 hours for 48 hours, followed by an extended treatment period of every 3 hours until 32 weeks corrected gestational age

oropharyngeal mother's milk

oropharyngeal sterile water OTHER

Application of 0.2 mL of sterile water onto the infant's oral mucosa, for an initial treatment period of every 2 hours for 48 hours, followed by an extended treatment period of every 3 hours until 32 weeks corrected gestational age

oropharyngeal sterile water

Eligibility Criteria

• Age: 1 Day - 4 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birthweight \<1250g Mother plans to pump and provide breastmilk for at least 2 months Absence of severe congenital anomalies Admission to the neonatal intensive care unit within 24 hours after birth Ability to begin protocol within 96 hours of life

You may not qualify if:

• Gastrointestinal anomaly pH \< 7.0 on initial blood gas in NICU Maternal +HIV status Maternal drug or substance use that precludes infant from receiving mother's milk Tracheoesophageal fistula

Sponsors & Collaborators

• Endeavor Health: lead
• The Gerber Foundation: collaborator
• Fundacion Para La Investigacion Hospital La Fe: collaborator
• University of Chicago: collaborator

Study Sites (5)

South Miami Hospital

Miami, Florida, 33143-4679, United States

Location

NorthShore University health System

Evanston, Illinois, 60201, United States

Location

Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, 60068, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Betty Cameron Women & Children's Hospital

Wilmington, North Carolina, 28403-6024, United States

Location

Related Publications (2)

• Rodriguez NA, Moya F, Ladino J, Zauk A, Prazad P, Perez J, Vento M, Claud E, Wang CH, Caplan MS. A randomized controlled trial of oropharyngeal therapy with mother's own milk for premature infants. J Perinatol. 2023 May;43(5):601-607. doi: 10.1038/s41372-022-01589-x. Epub 2023 Jan 3.

  PMID: 36596945 DERIVED

• Rodriguez NA, Vento M, Claud EC, Wang CE, Caplan MS. Oropharyngeal administration of mother's colostrum, health outcomes of premature infants: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:453. doi: 10.1186/s13063-015-0969-6.

  PMID: 26458907 DERIVED

MeSH Terms

Conditions

Infections; Enterocolitis, Necrotizing; Pneumonia, Ventilator-Associated; Premature Birth

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Healthcare-Associated Pneumonia; Cross Infection; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Nancy A Garofalo (previously Rodriguez), PhD APN NNP

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 17, 2014
• Study Start: November 20, 2013
• Primary Completion: October 30, 2021
• Study Completion: January 4, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (5)