| Patel and Shaikh,19 2007, India |
To evaluate the effects of gastric lavage with breast milk in premature newborns compared to the use of exclusive parenteral feeding |
Intervention group (n=40)
Control group (n=40)
Weight <1,750g
GA <36 weeks |
Intervention:
Gastric lavage every 3 h with 5 mL of their own mother’s milk started within 4 hours of birth until the start of enteral diet with 3 ml/Kg.
Control:
Use of exclusive parenteral fluids |
The intervention reduced the number of days on parenteral fluids, risk of sepsis and length of hospital stay. |
Intervention - 2
Control - 2
p=0.3
Not significant |
Rodriguez et al.,20
2011, United States |
To evaluate the effects of administering oropharyngeal colostrum to very low birth weight premature infants on their clinical outcomes. |
Intervention group
(n = 9)
Control group
(n = 6)
Weight <1,000g
GA <28 weeks |
Intervention:
Use 0.2 mL of mother’s own colostrum via oropharyngeal route every 2 hours for 48 consecutive hours.
Control:
Use of sterile water (placebo) via oropharynx every 2 hours for 48 consecutive hours. |
Significant reduction in time to complete enteral feeding for PTNB treated with mother’s own colostrum. |
Intervention - 2
Control - 0
p=0,486
Not significant |
| Lee et al.,26 2015, Korea |
To evaluate the immunological effects of oropharyngeal colostrum administration in very low birth weight premature infants. |
Intervention group
(n = 24)
Control group (n = 24)
Weight <1,003g
GA <28 weeks |
Intervention:
Use of 0.2 mL of colostrum via oropharyngeal route every 3 hours for 3 days, starting between 48 and 96 hours of life.
Control:
Use of sterilized water via the oropharynx every 3 hours for 3 days, starting between 48 and 96 hours of life. |
The administration of oropharyngeal colostrum reduces clinical sepsis, inhibits the secretion of pro-inflammatory cytokines and increases circulating levels of immunoprotective factors. |
Intervention - 3
Control - 6
p=0.46
Not significant |
| Sohn et al.,25 2016, United States |
To evaluate the impact of oropharyngeal colostrum administration on the composition of the oral microbiota in PTNB. |
Intervention Group - 6 Control Group - 6
Weight <1,500g
GA ≤30 weeks. |
Intervention:
Use of 0.2 mL of the mother’s colostrum in the oral cavity (0.1 mL on each side of the cavity) every 2 hours for 46 hours, regardless of whether the RNPT-MBP was receiving trophic food.
Control:
Received routine care. |
The oropharyngeal colostrum administration influenced the colonization of the oral cavity, with differences that persisted 48 hours after the end of the intervention. |
Intervention - 0
Control - 1
p=not referred |
Abd-Elgawad, et al.,27
2019, Eypgt |
To evaluate the impact of administering oropharyngeal colostrum on reducing nosocomial sepsis. |
Intervention group
(n = 100)
Control group
(n = 100)
Weight <1,500g
GA < 32 weeks. |
Intervention:
Use of 0.2 mL of maternal colostrum by dropper in the oropharyngeal pouch, tongue and cheeks every 2-4 hours, minutes before feeding by gavage.
Control:
Use of regular gavage with breast milk. |
The intervention did not reduce sepsis, but had a beneficial effect on the early introduction of enteral feeding and on reducing the time to hospital discharge. |
Intervention - 11
Control - 16
p=0.31
Not significant
*Stratification for age 28 week: not significant. |
Hariharan, et al.,28
2017, India |
To evaluate the effects of oropharyngeal administration of colostrum on late-onset sepsis in LBWN. |
Intervention group (n=56)
Control group (N=56)
Weight <1,250G
GA < 32 weeks. |
Intervention:
Use on the buccal mucosa of 0.2 mL of breast milk via syringe (0.1ml on each side of the mouth) every 6 hours, until 30 weeks corrected gestational age or the start of oral feeding.
Control:
Use of routine enteral feeding. |
Oropharyngeal colostrum administration is feasible, safe and associated with a lower incidence of feeding intolerance and
incidence of feeding intolerance and nosocomial sepsis in extreme prematurity. |
Intervention - 2
Control - 2
p=not referred |
Ferreira, et al.,21
2019, Brazil |
To evaluate the effects of administering oropharyngeal colostrum on the incidence of clinical and proven late-onset sepsis and on immunoglobulin A (IgA) concentrations in very low birth weight newborns. |
Intervention Group
(n = 47)
Control group
(n = 66)
Weight <1,500g
GA < 34 weeks. |
Intervention:
Use of 0.2 mL of maternal colostrum in the first 48 or 72 hours of life every 2 hours for 48 hours, 0.1 mL on the right oral mucosa and 0.1 mL on the left.
Control:
Use of 0.2 mL sterile water in the first 48 or 72 hours of life every 2 hours for 48 hours, 0.1 mL on the right oral mucosa and 0.1 mL on the left |
This study could not confirm the hypothesis that oropharyngeal administration of maternal colostrum can reduce the incidence of late-onset sepsis and increase IgA levels. |
Intervention - 2
Control - 8
p=not referred |
Sharma, et al.,8
2020, India |
To evaluate the effects of administering oropharyngeal colostrum to very low birth weight newborns in reducing necrotizing enterocolitis |
Intervention Group
(n = 59)
Control group
(n = 58)
Weight ≤1,250g
GA ≤30 weeks. |
Intervention:
Use 0.2 mL of maternal colostrum on the oral mucosa, 0.1 mL on each side. Started after 24 hours of birth every 2 hours for 72 hours of life.
Control:
Received routine care. |
Oropharyngeal colostrum administration is safe and reduces the length of hospital stay; however, it does not reduce the incidence of enterocolitis. |
Intervention - 3
Control - 4
p=0.72
Not significant |
Aggarwal et al.,29
2021, India |
To evaluate the effects of administering oropharyngeal colostrum on reducing morbidity and mortality in premature newborns. |
Intervention group (n=130)
Control group (n=130)
Weight: not identified
GA <26-31 weeks. |
Intervention:
Use of 0.2 mL of colostrum on the oral mucosa every 3 hours, starting after 24h of life and continued until oral feeding was started.
Control:
Use of 0.2 mL of sterile water on the oral mucosa every 3 hours, starting after 24 hours of life and continued until oral feeding was started. |
Oropharyngeal colostrum administration of in neonates did not reduce the primary outcome of death, late-onset sepsis or necrotizing enterocolitis. |
Intervention - 30
Control - 28
p=0.76
Not significant |
| Sudeep et al.,30 2022, India. |
To evaluate the effects of administering oropharyngeal colostrum on clinical outcomes in premature infants between 26 and 30 weeks of gestation. |
Intervention group (n=66)
Control group (n=67)
Weight: not identified
GA: 26-30 weeks. |
Intervention:
Use 0.2 mL of maternal colostrum on the oral mucosa, 0.1 mL on each side every 3 h., started at 24-72 h. of life, until 32 post-menstrual age and or start of oral feeding.
Control:
Use of 0.2 mL of distilled water on the oral mucosa, 0.1 mL on each side every 3 hours, started within 24-72 hours of life, up to 32 hours of post-menstrual age and/or the start of oral feeding. |
The intervention reduced the
incidence of late-onset sepsis and was considered a safe therapy. |
Intervention - 10
Control -17
p=0.1
Not significant |
Romero-Maldonado,
et al.,22 2022, Mexico |
To evaluate the effect of oropharyngeal administration of colostrum vs. placebo in the first 4 days of life in premature newborns ≤32 weeks of gestation on serum Immunoglobulin concentration, neonatal morbidity and total hospitalization days. |
Intervention Group
(n =46)
Control Group (n =50)
Weight: not identified
GA <32 weeks. |
Intervention:
Use of 0.3 mL of colostrum every 4hs, started from 24 postnatal for 4 days.
Control:
Use of 0.3 mL of distilled water every 4hs, started from 24 postnatal for 4 days. |
The intervention increased serum IgA concentration on the 28th day of life, decreased the time to achieve full enteral feeding, birth weight recovery and length of hospital stay |
Intervention - 0
Control - 6
p=0.06
Not significant |
| Jain et al.,32 2022, India |
To evaluate the effect of oral hygiene with the mother’s own breast milk on late-onset sepsis, mortality, days to obtain full enteral feeding, necrotizing enterocolitis, exclusive breastfeeding rates at discharge and total hospital days. |
Intervention group = 55
Control group = 55
Weight <1,500g
GA: not reported. |
Intervention:
Use of 0.1 ml of mother’s own milk through oral hygiene every 8 hours until oral feeding was achieved.
Control:
Received oral care without breast milk. |
The intervention proved to be simple and safe, with a statistically significant reduction in late-onset sepsis and a non-significant reduction in mortality (secondary outcome) and an increase in exclusive breastfeeding rates at discharge. |
Intervention - 5
Control - 9
p=0.252
Not significant |
| Rodriguez et al.,23 2023, United States |
To evaluate the effect of oropharyngeal colostrum administration vs. placebo in reducing late-onset sepsis, necrotizing enterocolitis, death, length of hospital stay, time to complete enteral nutrition and complete oral feeding in premature infants |
Intervention Group = 113
Control group = 107
Weight <1,250g
GA: not reported. |
Intervention:
Use of 0.2 mL of mother’s own colostrum via the oropharynx every 2 hours for 48 consecutive hours, then every 3 hours until 32 weeks corrected gestational age.
Control:
Use of sterile water (placebo) via the oropharynx every 2 hours for 48 consecutive hours, then every 3 hours until 32 weeks of corrected gestational age. |
The intervention did not reduce sepsis, necrotizing enterocolitis or death. There was a trend towards shorter hospital stays and better nutritional outcomes, but the results were not statistically significant. |
Intervention - 4
Control - 3
p>0.05
Not significant |
| Mannan et al.,31 2023, Bangladesh |
To evaluate the effect of oropharyngeal administration of colostrum on reducing the rates of necrotizing enterocolitis and mortality in premature infants |
Intervention Group = 52
Control group = 40
Weight <1,800g
GA: 34 weeks |
Intervention:
Use 0.2 mL of mother’s own colostrum via oropharyngeal route, after 24 to 48h postnatal, every 3 hours for 72 consecutive hours.
Control:
Received routine care |
There was a positive effect on reducing the rate of necrotizing enterocolitis and the survival rate. |
Intervention - 5
Control - 10
p=not referred |
Easo et al.,24 2021,
Kuwait |
To evaluate the effect of oral therapy with colostrum or breast milk on clinical outcomes. |
Intervention group = 24
Control Group = 24
Weight <1,500g
GA: <33 weeks. |
Intervention:
Use 0.2 mL of colostrum or breast milk by the oropharyngeal route, every 4 hours until oral feeding begins.
Control:
Use of 0.2 mL of saline solution by oropharyngeal route, every 4 hours until oral feeding begins. |
Oral therapy with colostrum or breast milk reduces the time to hospital discharge. |
Intervention - 2
Control - 0
p>0.05
Not significant |
Oropharyngeal colostrum immunotherapy in premature newborns and neonatal mortality: a systematic review with meta-analysis
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REBEC=Registro Brasileiro de Ensaios Clínicos; CAPES= Coordenação de Aperfeiçoamento de Pessoal de Nível Superior; PRISMA=Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
Source: RoB 2, 2023.
OCI = Oropharyngeal Colostrum Immunotherapy.Source: Stata 16.