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

Fudan University logo

Fudan University

Status

Completed

Conditions

Premature Infants

Treatments

Behavioral: Routine nursing care group
Behavioral: Complete oral feeding intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05208437
[2021]394

Details and patient eligibility

About

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

Full 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.

Enrollment

148 patients

Sex

All

Ages

Under 72 hours old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

148 participants in 2 patient groups

Complete oral feeding intervention group
Experimental group
Description:
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.
Treatment:
Behavioral: Complete oral feeding intervention
Routine nursing care group
Active Comparator group
Description:
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.
Treatment:
Behavioral: Routine nursing care group

Trial contacts and locations

1

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Central trial contact

Xiaojing Hu, PhD; Li Wang, Bachelor

Data sourced from clinicaltrials.gov

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