Splanchnic Oxygenation Response to Enteral Feeds in Preterm Infants With Abnormal Antenatal Doppler.

NCT02971566 | Completed

• 1 other identifier: SO-2016-AREDF
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Antenatal absent or reversed end-diastolic flow (AREDF) velocity through the umbilical arteries places preterm infants at significant risk for developing gastrointestinal complications, such as feeding intolerance, necrotizing enterocolitis or spontaneous intestinal perforation. Due to the fear of the aforementioned conditions, the establishment of adequate enteral feeds is frequently hampered in this population. Previous postnatal Doppler studies have shown that AREDF preterm infants who later developed feeding intolerance have a decreased blood flow velocity in the superior mesenteric artery in response to the first enteral feed; to date, however, it is not known whether this hemodynamic impairment persists over time, or if it is associated with reduced splanchnic oxygenation and perfusion, monitored by Near-infrared spectroscopy (NIRS). This observational prospective study aims:

• to assess the patterns of abdominal oxygenation and perfusion in response to enteral feeds in AREDF preterm infants at different phases of enteral feeding establishment;
• to evaluate a possible correlation with the development of gastrointestinal complications.

Conditions

Placental Insufficiency; NEC - Necrotizing Enterocolitis; Newborn, Premature; Feeding Disorder Neonatal

Keywords

feeding intolerance; preterm infants; near infrared spectroscopy; abnormal antenatal Doppler

Outcome Measures

Primary Outcomes (1)

• Increase/reduction of SrSO2 after enteral feeds

  Increase/reduction of SrSO2 values in response to enteral feeds in infants who have developed gastrointestinal complications during their hospitalization.

  3.5 hours

Secondary Outcomes (1)

• Increase/reduction of FSOE after enteral feeds

  3.5 hours

Study Arms (2)

Gastrointestinal complications

Development of one ore more of the following gastrointestinal complications: * necrotizing enterocolitis (stage ≥2) * spontaneous intestinal perforation * feeding intolerance, defined as enteral feeding withholding ≥1 day because of suggestive clinical signs

Controls

no evidence of gastrointestinal complications during the hospitalization

Eligibility Criteria

• Age: 1 Day - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

20 preterm infants admitted to the Neonatal Intensive Care Unit of Sant'Orsola-Malpighi University Hospital and fulfilling the inclusion criteria are going to be enrolled.

You may qualify if:

• gestational age ≤34 weeks
• stable clinical conditions
• documented evidence of antenatal umbilical Doppler impairment
• written informed consent obtained from parents/guardians

You may not qualify if:

• Enteral feeding prior to the enrollment
• Major congenital abnormalities (including congenital heart diseases, gastroschisis, exomphalos)
• Hemodynamic instability, hypotension, patent ductus arteriosus, anemia, sepsis or other infections at time of NIRS monitoring

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital

Bologna, Italy, 40138, Italy

Location

Related Publications (4)

• Kempley S, Gupta N, Linsell L, Dorling J, McCormick K, Mannix P, Juszczak E, Brocklehurst P, Leaf A; ADEPT Trial Collaborative Group. Feeding infants below 29 weeks' gestation with abnormal antenatal Doppler: analysis from a randomised trial. Arch Dis Child Fetal Neonatal Ed. 2014 Jan;99(1):F6-F11. doi: 10.1136/archdischild-2013-304393. Epub 2013 Aug 23.

  PMID: 23973795 BACKGROUND

• Bora R, Mukhopadhyay K, Saxena AK, Jain V, Narang A. Prediction of feed intolerance and necrotizing enterocolitis in neonates with absent end diastolic flow in umbilical artery and the correlation of feed intolerance with postnatal superior mesenteric artery flow. J Matern Fetal Neonatal Med. 2009 Nov;22(11):1092-6. doi: 10.3109/14767050903029600.

  PMID: 19900051 BACKGROUND

• Kempley ST, Gamsu HR, Vyas S, Nicolaides K. Effects of intrauterine growth retardation on postnatal visceral and cerebral blood flow velocity. Arch Dis Child. 1991 Oct;66(10 Spec No):1115-8. doi: 10.1136/adc.66.10_spec_no.1115.

  PMID: 1750758 BACKGROUND

• Martini S, Aceti A, Beghetti I, Faldella G, Corvaglia L. Feed-related Splanchnic Oxygenation in Preterm Infants With Abnormal Antenatal Doppler Developing Gut Complications. J Pediatr Gastroenterol Nutr. 2018 May;66(5):755-759. doi: 10.1097/MPG.0000000000001804.

  PMID: 29112084 DERIVED

MeSH Terms

Conditions

Placental Insufficiency; Enterocolitis, Necrotizing; Premature Birth

Condition Hierarchy (Ancestors)

Placenta Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Luigi T Corvaglia, Prof

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, University of Bologna (Italy)

Study Record Dates

• First Submitted: November 19, 2016
• First Posted: November 23, 2016
• Study Start: February 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 23, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)