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CompletedNCT05208437Updated Aug 14, 2023

Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants

An interventional study of Complete oral feeding intervention and Routine nursing care group in Premature Infants, sponsored by Children's Hospital of Fudan University. Completed at 1 site in China. Open to participants aged 0 Hours to 72 Hours. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Children's Hospital of Fudan University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
0 Hours to 72 Hours
Sex
All
01

Study summary

Non-nutritive sucking combined with a step-by-step oral feeding regimen shortens the total oral feeding cycle in premature infants

Read the detailed description

In order to improve the feeding of premature infants \<32 weeks of gestation, a complete oral feeding intervention program is provided for premature infants, which combined the evaluation of oral feeding readiness, the evaluation of oral feeding performance, non-nutritional sucking intervention and progressive feeding program. Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale.

Assess the premature infants by using the Feeding Preparation Scale. If the premature infant does not meet the oral feeding standard, let the premature infant use the non-nutritive sucking for 3 minutes before the nasal feeding; if the premature infant meets the oral feeding standard, use the non-nutritive sucking for 3 minutes, and refer to the feeding schedule for the premature infant. The whole intervention stops until the premature infant achieves the full oral feeding. Length of time required for complete oral feeding of premature infants is compared between the intervention group and the control group to evaluate the effect of the complete oral feeding intervention program on improving the feeding of premature infants \<32 weeks of gestation.

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Conditions studied

  • Premature Infants

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Keywords

  • premature infants
  • oral feeding
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 148 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Hours to 72 Hours
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Gestational age \<32w;
  • Admit within 72 hours of birth;
  • The guardian signs the informed consent;
  • OI (oxygenation index >300)

Exclusion criteria

Exclusion Criteria:

  • Newborns with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;
  • Newborns who die during the study;
  • Newborns who drop out of the study;
  • Newborns who have NEC during hospitalization
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
148 participants (actual)

Study arms

  • Experimental
    Complete oral feeding intervention group

    Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale. Feeding of premature infants using different interventions based on the results of the Feeding Preparation Scale.

    Behavioral: Complete oral feeding intervention

  • Active comparator
    Routine nursing care group

    Pre-feeding assessments will be performed from premature infants corrected for gestational age at 34 weeks. If the baby's vital signs are stable, the method of oral feeding and then nasal feeding is used, and feeding 8 to 12 times a day until the baby reaches complete oral feeding. Routine nursing care is identical to the control group.

    Behavioral: Routine nursing care group

Interventions

  • BehavioralComplete oral feeding intervention

    Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale by trained nurses. Assess the premature infants by using the Feeding Preparation Scale. If the premature infant does not meet the oral feeding standard, let the premature infant use the non-nutritive sucking for 3 minutes before the nasal feeding. If the premature infant meets the oral feeding standard, use the non-nutritive sucking for 3 minutes, and refer to the feeding schedule for the premature infant.

  • BehavioralRoutine nursing care group

    Pre-feeding assessments will be performed from premature infants corrected for gestational age at 34 weeks. If the baby's vital signs are stable, the method of oral feeding and then nasal feeding is used, and feeding 8 to 12 times a day until the baby reaches complete oral feeding.

06

What researchers measure

Primary outcomes

  1. Transition time from the initiation oral feeding to full oral feeding

    Transition time was defined as the days needed from introduction of oral feeding to obtain autonomous oral feeding when the nasogastric tube was removed and all the daily milk volume was taken from the bottle. time of complete oral feeding

    Time frame: During the procedure

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Study locations

1 site
  • Children's Hospital of Fudan University
    Shanghai, Shanghai 201102, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05208437
Lead sponsor
Children's Hospital of Fudan University
Responsible party
Sponsor
First posted
Jan 26, 2022
Start date
Feb 1, 2022
Primary completion
Jun 30, 2023
Completion
Jul 31, 2023
Last update
Aug 14, 2023

Study contacts

Xiaojing Hu, PhD
principal investigator · Children's Hospital of Fudan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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