NCT00365703

Brief Summary

The purpose of this study is to find out which method (nasogastric vs. orogastric) of feeding tube for premature infants results in earlier only oral feeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2006

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

First Submitted

Initial submission to the registry

August 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 19, 2007

Status Verified

December 1, 2007

First QC Date

August 15, 2006

Last Update Submit

December 15, 2007

Conditions

Infant, Premature

Keywords

Infant, PrematureTube feeding

Outcome Measures

Primary Outcomes (1)

  • The mean post conceptual age at which the infant is fed orally only.

    1 year

Study Arms (2)

1

EXPERIMENTAL

Orogastric feeding tube.

Procedure: Feeding tube insertion

2

EXPERIMENTAL

Nasogastric feeding tube.

Procedure: Feeding tube insertion

Interventions

Feeding tube insertionPROCEDURE

1. Orogastric feeding tube 2. Nasogastric feeding tube

12

Eligibility Criteria

AgeUp to 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All preterm infants, born during one year, who required tube feeding, and later discharged from neonatal intensive care unit.

You may not qualify if:

  • Infants who died during hospitalization
  • Infants with severe neurologic deficit (e.g. after Sarnat II-III asphyxia, or as a part of a syndrome
  • Infants with gastrostomy
  • Infants who were transferred to another hospital for any reason (e.g. heart surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal intensive care unit, Hille Yaffe medical center

Hadera, Hadera, 38100, Israel

Location

Related Publications (12)

  • Lau C, Smith EO, Schanler RJ. Coordination of suck-swallow and swallow respiration in preterm infants. Acta Paediatr. 2003 Jun;92(6):721-7.

    PMID: 12856985BACKGROUND

  • Mizuno K, Ueda A. The maturation and coordination of sucking, swallowing, and respiration in preterm infants. J Pediatr. 2003 Jan;142(1):36-40. doi: 10.1067/mpd.2003.mpd0312.

    PMID: 12520252BACKGROUND

  • Shiao SY, Youngblut JM, Anderson GC, DiFiore JM, Martin RJ. Nasogastric tube placement: effects on breathing and sucking in very-low-birth-weight infants. Nurs Res. 1995 Mar-Apr;44(2):82-8.

    PMID: 7892144BACKGROUND

  • Haxhija EQ, Rosegger H, Prechtl HF. Vagal response to feeding tube insertion in preterm infants: has the key been found? Early Hum Dev. 1995 Mar 17;41(1):15-25. doi: 10.1016/0378-3782(94)01605-o.

    PMID: 7781566BACKGROUND

  • Grunebaum M, Horodniceanu C, Wilunsky E, Reisner S. Iatrogenic transmural perforation of the oesophagus in the preterm infant. Clin Radiol. 1980 May;31(3):257-61. doi: 10.1016/s0009-9260(80)80211-x.

    PMID: 7428263BACKGROUND

  • Arvedson JC, Lefton-Greif MA. Anatomy, physiology, and development of feeding. Semin Speech Lang. 1996 Nov;17(4):261-8. doi: 10.1055/s-2008-1064103.

    PMID: 8979310BACKGROUND

  • Lau C, Schanler RJ. Oral motor function in the neonate. Clin Perinatol. 1996 Jun;23(2):161-78.

    PMID: 8780899BACKGROUND

  • Stevenson RD, Allaire JH. The development of normal feeding and swallowing. Pediatr Clin North Am. 1991 Dec;38(6):1439-53. doi: 10.1016/s0031-3955(16)38229-3.

    PMID: 1945550BACKGROUND

  • Pinelli J, Symington A. Non-nutritive sucking for promoting physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2001;(3):CD001071. doi: 10.1002/14651858.CD001071.

    PMID: 11686975BACKGROUND

  • Simpson C, Schanler RJ, Lau C. Early introduction of oral feeding in preterm infants. Pediatrics. 2002 Sep;110(3):517-22. doi: 10.1542/peds.110.3.517.

    PMID: 12205253BACKGROUND

  • Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. doi: 10.1067/mpd.2002.125731.

    PMID: 12183719BACKGROUND

  • Suess PE, Alpan G, Dulkerian SJ, Doussard-Roosevelt J, Porges SW, Gewolb IH. Respiratory sinus arrhythmia during feeding: a measure of vagal regulation of metabolism, ingestion, and digestion in preterm infants. Dev Med Child Neurol. 2000 Mar;42(3):169-73. doi: 10.1017/s001216220000030x.

    PMID: 10755456BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Intubation, Gastrointestinal

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

IntubationTherapeuticsInvestigative Techniques

Study Officials

  • Erez Nadir, MD

    Hillel Yaffe medical cenetr, Hadera, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 15, 2006

First Posted

August 17, 2006

Study Start

September 1, 2006

Study Completion

August 1, 2007

Last Updated

December 19, 2007

Record last verified: 2007-12

Locations

IL(1)