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| Name | Class |
|---|---|
| The Gerber Foundation | OTHER |
| Fundacion Para La Investigacion Hospital La Fe | OTHER |
| University of Chicago | OTHER |
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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.
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. This 5-year placebo-controlled, double-blind randomized controlled trial will evaluate the safety, efficacy and health outcomes of oropharyngeal administration of OMC/OMM in a sample of 622 (total patients enrolled) extremely premature infants with the following aims: Aim 1. To determine if oropharyngeal administration of OMC/OMM to extremely premature infants will reduce the risk of late-onset sepsis or death as the primary outcome, and necrotizing enterocolitis and ventilator-associated pneumonia as pre-planned secondary outcomes. Aim 2: To determine if extremely premature infants who receive OMC/OMM via the oropharyngeal route have a shorter time to reach full enteral feeds and a shorter length of hospital stay. Aim 3: To determine if oropharyngeal administration of OMC/OMM will have immunostimulatory effects for extremely premature infants, as measured by (A) enhancement of gastrointestinal (fecal) microbiota, (B) improvement in antioxidant defense maturation or reduction of pro-oxidant status, and (C) maturation of immunostimulatory effects as measured by changes in urinary lactoferrin. Results will confirm whether extremely premature infants demonstrate a host-immune response to this intervention and whether there is a beneficial effect on common morbidities in these high risk patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach full enteral feeds | defined as # days to reach a 120kcal/kg/day | at 40 wks CGA |
| Length of hospital stay | at 40 wks CGA | |
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Inclusion Criteria:
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
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Nancy A Garofalo (previously Rodriguez), PhD APN NNP | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Miami Hospital | Miami | Florida | 33143-4679 | United States | ||
| NorthShore University health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36596945 | Derived | 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. | |
| 26458907 | 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. |
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| 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 |
|
| 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 | 1 day, 3 days, 1 week, 32 weeks CGA | 3 days, |
| Evanston |
| Illinois |
| 60201 |
| United States |
| Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois | 60068 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Betty Cameron Women & Children's Hospital | Wilmington | North Carolina | 28403-6024 | United States |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020345 | Enterocolitis, Necrotizing |
| D053717 | Pneumonia, Ventilator-Associated |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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