NCT02383264

Brief Summary

Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm infants are at high risk of developing feeding intolerance (FI) or necrotizing enterocolitis (NEC), which is the most feared gastrointestinal complication of prematurity. The occurrence of FI often prompts clinicians to withhold, decrease or discontinue enteral feeds; thus, the establishment of an adequate early enteral nutrition is frequently hampered. Early identification of preterm infants at high risk for gastrointestinal complications could help clinical decisions on the introduction and the advancement of enteral feeding. Near-infrared spectroscopy (NIRS) provides a non-invasive monitoring of regional oxygen saturation (rSO2). A significant correlation between lower abdominal rSO2 values in the first week of life and subsequent NEC development has been reported. To date, however, splanchnic oxygenation patterns in response to the first bolus feed and possible correlations with subsequent FI development have not been yet established. This observational prospective study aims:

  • to assess abdominal rSO2 patterns in response to the first bolus feed;
  • to evaluate possible correlations with subsequent development of gastrointestinal complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

2.1 years

First QC Date

March 4, 2015

Last Update Submit

November 19, 2016

Conditions

Necrotizing EnterocolitisVery Low Birth Weight Infants

Keywords

feeding intolerancepreterm infantsnear infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Increase/reduction of abdominal rSO2 values after the first enteral feed in infants at high risk of feeding intolerance.

    Increase/reduction of abdominal rSO2 values in response to the first enteral feed in infants who have further developed feeding intolerance during their hospitalization.

    3.5 hours

Study Arms (2)

feeding intolerance

Development of feeding intolerance, defined as enteral feeding withholding for at least 1 day due to the onset ofgastrointestinal clinical symptoms

normal feeding tolerance

no evidence of feeding intolerance during the hospitalization

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Due to the exploratory nature of this study, at least 60 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

You may not qualify if:

  • Any enteral feeding prior to the enrollment.
  • Major congenital abnormalities
  • Central nervous system diseases
  • Hypoxic injury
  • Hemodynamic instability, hypotension, patent ductus arterioles, anemia, sepsis or other infections at time of first feed.
  • Antenatal Doppler impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bologna, Italy, 40138, Italy

Location

Related Publications (1)

  • Corvaglia L, Martini S, Battistini B, Rucci P, Faldella G, Aceti A. Splanchnic Oxygenation at First Enteral Feeding in Preterm Infants: Correlation With Feeding Intolerance. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):550-554. doi: 10.1097/MPG.0000000000001308.

    PMID: 27467111DERIVED

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Luigi T Corvaglia, Prof

    S. Orsola-Malpighi Hospital, University of 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

March 4, 2015

First Posted

March 9, 2015

Study Start

February 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations

IT(1)