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Completed

NCT Number: NCT05208437

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

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

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Key information

Age range

0 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Complete oral feeding intervention

Behavioral

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.

Routine nursing care group

Behavioral

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.

Primary outcomes

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

    Time frame: During the procedure

    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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants Whose Corrected Gestational Age Are Less Than 32 Weeks

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2022
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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