Infant, PrematureNCT00365703
Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best?
A study testing Feeding tube insertion in people with Infant, Premature, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Infant, Premature
- What is being tested?
- Feeding tube insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2006to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All preterm infants, born during one year, who required tube feeding, and later discharged from neonatal intensive care unit.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Neonatal intensive care unit, Hille Yaffe medical center
Hadera, Hadera, 38100
About this study
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.
Read the detailed description
Preterm infants, even as young as 23 weeks gestational age, can be fed enterally at the first week of life. Coordination of sucking and swallowing, and coordination of both and breathing is necessary for efficient and safe oral feeding, and is not well established before the 35th week gestational age. That is why tube feeding is essential for preterm infants younger than that age.
There is no consensus regarding the best way for the feeding tube, i.e. oral vs. nasal, and whether placing the tube should be continuous or intermittently. Nasogastric tube has been associated with vagal responses. Both tubes may cause gastric perforation.
Development and function of oral feeding has been described. It is known that non-nutritive sucking and early introduction of oral feeding accelerate the transition from tube feeding to oral feeding. It is suggested that the preterm infant may experience a maturational lag in vagal function related to ingestive needs, which may contribute to continued feeding difficulties and may be a measurable marker of subtle neurodevelopmental problems. Both oral and nasal feeding tube may interfere with establishment of efficient oral feeding. The purpose of this study is to see whether there is a difference between oral and nasal tube feeding, regarding the institution of oral feeding.
- Conditions
- Infant, Premature
- Being tested
- Feeding tube insertion
- Keywords
- Infant, Premature, Tube feeding
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding tube insertionProcedure or surgery
- Orogastric feeding tube
- Nasogastric feeding tube
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Orogastric feeding tube. Receives: Procedure: Feeding tube insertion |
| 2 | Experimental | Nasogastric feeding tube. Receives: Procedure: Feeding tube insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean post conceptual age at which the infant is fed orally only.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startSep 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Investigators
- Erez Nadir, MD, Principal investigator, Hillel Yaffe medical cenetr, Hadera, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365703
- Sponsor's protocol ID
- 17/2006-1-HY-CTIL
- Status last verified
- Dec 2007
- First submitted
- 15 Aug 2006
- Last updated
- 19 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lau C, Smith EO, Schanler RJ. Coordination of suck-swallow and swallow respiration in preterm infants. Acta Paediatr. 2003 Jun;92(6):721-7.
PubMed 12856985Mizuno 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.
PubMed 12520252Shiao 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.
PubMed 7892144Haxhija 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.
PubMed 7781566Grunebaum 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.
PubMed 7428263Arvedson 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.
PubMed 8979310Lau C, Schanler RJ. Oral motor function in the neonate. Clin Perinatol. 1996 Jun;23(2):161-78.
PubMed 8780899Stevenson 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.
PubMed 1945550Pinelli 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.
PubMed 11686975Simpson 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.
PubMed 12205253Fucile 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.
PubMed 12183719Suess 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.
PubMed 10755456
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best?
- ClinicalTrials.gov ID
- NCT00365703
- Acronym / sponsor ID
- 17/2006-1-HY-CTIL
- Conditions
- Infant, Premature
- Keywords
- Infant, Premature, Tube feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Sep 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 17 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preterm infants, even as young as 23 weeks gestational age, can be fed enterally at the first week of life. Coordination of sucking and swallowing, and coordination of both and breathing is necessary for efficient and safe oral feeding, and is not well established before the 35th week gestational age. That is why tube feeding is essential for preterm infants younger than that age.
There is no consensus regarding the best way for the feeding tube, i.e. oral vs. nasal, and whether placing the tube should be continuous or intermittently. Nasogastric tube has been associated with vagal responses. Both tubes may cause gastric perforation.
Development and function of oral feeding has been described. It is known that non-nutritive sucking and early introduction of oral feeding accelerate the transition from tube feeding to oral feeding. It is suggested that the preterm infant may experience a maturational lag in vagal function related to ingestive needs, which may contribute to continued feeding difficulties and may be a measurable marker of subtle neurodevelopmental problems. Both oral and nasal feeding tube may interfere with establishment of efficient oral feeding. The purpose of this study is to see whether there is a difference between oral and nasal tube feeding, regarding the institution of oral feeding.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Feeding tube insertionOrogastric feeding tube. |
| 2 | Experimental | Procedure: Feeding tube insertionNasogastric feeding tube. |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All preterm infants, born during one year, who required tube feeding, and later discharged from neonatal intensive care unit.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feeding tube insertion1. Orogastric feeding tube 2. Nasogastric feeding tube | Procedure or surgery | 1, 2 |
Primary outcome
The mean post conceptual age at which the infant is fed orally only.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2007.
- Background: PubMed 12856985Lau C, Smith EO, Schanler RJ. Coordination of suck-swallow and swallow respiration in preterm infants. Acta Paediatr. 2003 Jun;92(6):721-7.
- Background: PubMed 12520252Mizuno 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.
- Background: PubMed 7892144Shiao 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.
- Background: PubMed 7781566Haxhija 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.
- Background: PubMed 7428263Grunebaum 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.
- Background: PubMed 8979310Arvedson 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.
- Background: PubMed 8780899Lau C, Schanler RJ. Oral motor function in the neonate. Clin Perinatol. 1996 Jun;23(2):161-78.
- Background: PubMed 1945550Stevenson 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.
- Background: PubMed 11686975Pinelli 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.
- Background: PubMed 12205253Simpson 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.
- Background: PubMed 12183719Fucile 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.
- Background: PubMed 10755456Suess 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erez Nadir, MD principal investigator
Hillel Yaffe medical cenetr, Hadera, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding tube insertion in people with Infant, Premature, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean post conceptual age at which the infant is fed orally only. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00365703, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2007.